.
`.
`63568 = Federal Register /‘Vol. 55, No. 233 / 9Wedn'esday, December .41, 1991 / Rules andRegu-lations'
`W
`Authority: Secs. 201. 801. 501, 502 503. 505.
`506.507.5127516. 520. 001(3). 701. 704 705. 706
`of the Federal Food, Drug. and Cosmetic Act
`(21 U5.0 321. 331. 351. 352. 353. 355. 350. W357
`360b—360f. 3601'. 361(a).-37'1. 3‘74, 375. 376);
`secs. 215, 301. 302(8). 351. 354—36017 of the
`Public Health Service Act (42 USC. 216. 241.
`242(8). 262. 263b—263n).
`»
`'.2 Section 310.545 is amendedin
`, paragraph (111(7) by removing the entry
`.“Methdl” including the parenthetical
`:' statement and alphabetically adding the
`' entry “Menthol”, by revising the ,
`,
`,' introductory text of paragraph (d1. and
`by adding paragraph [d1(31 toread as
`' follows:
`,
`.
`' § 310.565 Drug products contalning
`certain active Ingredientsoffered over-the-
`Ii
`t
`1
`IV
`‘0
`i
`- counter (OTC-1 for certain uses.
`
`Subpart Gefnesewed]
`
`"Subpart Hébrug Products for the
`Control of Dandruff. Seborrheic .
`Dermatitis, and Psoriasis
`
`‘
`
`p
`‘
`§ 358.701 Scope.
`' (a) An over-the—counter dandruff.
`V seborrheic dermatitis. or psoriasis drug
`product111 a form suitable for topical
`application'is generally recognized as
`safe and effective and1,5 not misbranded
`if it meets each of the conditions'111 this -
`,' subpartand each general condition
`established1n:§ 330.1 of this chapter. I
`'
`(b1 References'111 this subpart to
`regulatory sections of the Code of
`Federal Regulations are to chapter 1 of
`title 21 unless otherwise noted.
`(5 358.703 Definitions.
`As used in thissubpart:
`(a) 0001 tar. .The tar used for
`medicinal purposes that'is obtained as a
`byproduct during the destructive
`distillation of bituminous coal, at
`temperatures in the range of 900 “C to
`1100 °C. It may be further processed
`using either extraction with alcohol and
`= suitable dispersing agents and.
`‘ maceration times or fractional
`‘ distillation with or without the use of
`suitable organic solvents.
`(b1 Dandruff. A condition involving an
`increased rate of shedding of dead
`epidermal cells of the scalp.
`(1:) Psoriasis. A condition of the soalp
`’ or body characterized by irritation,
`itching. redness. and extreme excess
`shedding of dead epidermal cells.
`((11 Seborrheic dermatitis. A condition
`of the scalp or body characterized by
`irritation. itching. redness, and excess
`shedding of dead epidermal cells.
`
`§ 358.710 Active ingredients for the
`control of dandruff, seborrhelc dermatitis.
`or psoriasis.
`
`The active ingredient of the product
`consists of any of the following within
`the specified concentration established
`for each ingredient:
`(31111317119 ingredients for the control
`of dandruff (11 Goal tar, 0.5 to 5 percent.
`When a coal tar solution. derivative. or
`fraction is used as the source of the coal
`tor. the labeling shall specify the
`identity and concentration of the coal
`tar source used and the concentration of
`the coal tar present in the final product.
`(2) Pyrithione zinc. 0.3 to 2 percent
`when formulated to be applied and then
`washed off after brief exposure.
`(31 Pyrithione zinc. 0.1 to 0.25 percent
`when formulated to be applied and left
`on the skin or scalp.
`(4) Salicylic acid? 18 to 3 percent.
`(5) Selenium sulfide, 1 percent.
`(61 Sulfur. Z to 5 percent.
`'
`
`.
`
`‘
`
`-
`
`_
`
`'
`
`(d) Any OTC drug produCt that'13 not
`in compliance with this section18
`.
`'
`' Subject to regulatory action if initially
`introduced or initially delivered for
`' introduction into interstate commerce
`' after the dates specifiedin paragraphs .
`i
`h
`((118.1. (d1(21. and (d1(31 of this section.
`1(3) December 4, 1992, for products "
`subject to paragraph (111(7) of this
`section that contain menthol as an
`antipruritic in combination with the
`antidandruff ingredient coal tar
`_ identified1n § 358.710Ea1(11 of this
`chapter.
`
`"
`
`PART SSE—MESCELLANEOUS
`
`EXTERNIRL DRUG snooocrs FOR
`OVER-THE—CGUNTER HUMAN U35
`
`3. The authority‘citation for 21 CFR
`part 358 continues to read as follows:
`11111111111131: Secs. 201, 501, 502. 503, 505. 510.
`701 of the Federal Food. Dragons] Cosmetic
`—Act (21 USE. 321. 351. 352. 353. 355. 360, 3'71).
`
`4. Subpart G is reserved and new
`subp‘art H. consisting of §§ 358.701
`through 358.750. is added to read as
`followe:
`Subpart o~rneservec1 '
`
`Support i-i-Drug Products for the Control
`oi'Dandrutf, Seborrhelc Dermatitis, and
`Psoriasis
`. Sec.
`' 358.701 Scope.
`3.58.703 Definitions.
`358.710 Active ingredients for the control of
`dandruff, seborrheic dermatitis. or
`psoriasis.
`358.720 Permitted combinations of active
`ingredients
`358.750 Labeling of drug products for the
`control of- dandruff sebo‘rrheic
`dermatitis. for psoriasis.
`
`I
`
`(b1 Active ingredients for the control
`ofseborrbeic dermatitis. (1) Coal tar. 0.5
`to 5 percent. When a coal tar solution.
`derivative. or fractionis used as the _
`source of the coal tar. the labeling shall
`specify the identity and concentration c.
`the coal tar source used and the
`
`concentration of the coal tar present1n
`the .final product
`(21 Pyrithione zinc, 0.95 to 2 percent
`when formulatedto be applied and then ,_ .
`washed Off after brief exposure.
`.
`[31 Pyrithione zinc. 0.1 to. 0.25 percent
`when formulated to be appliedand left
`on the skin or scalp.
`(4] Salicylic acid. 1.8 to 3 percent.
`(51 Selenium sulfide. 1 percent.
`(c1 Active ingredients for the con trol-
`ofpsoriasis. (1) Coal tar, 0.5 to 5 percent.
`When a coal tar solution. derivative, or
`fraction is used as the source of the coal
`tar, the labeling shall specify the
`identity'and concentration of the coal
`tar source used and the concentration of
`the coal tar present in the final product.
`p
`(21 Salicylic acid, 1.8103 percent.
`§ 358.720 Permitted combinations '91
`active ingredients.
`.
`
`Salicylic acid identified'in § 358.710(a1
`(41 may be combined with sulfur
`identified'in § 358.710(a1(6) provided .
`each ingredient13 present within the
`established concentration and the
`product is labeled for the control of
`dandruff.
`
`\
`
`§ 358.750 Labeling of drug products tor
`the control of dandruff, seborrheic
`dermatitis. or psoriasis.
`
`(a1 Statement of identity. The labeling
`of the product contains the established
`name of the drug. if any, and identifies
`the product with one or more of the
`following. as appropriate:
`(11 “Dandruff (insert product form1" or
`“'antidandruff_(insert product form)".
`(21 “Seborrheic dermatitis {insert
`product form)".
`(31 “Psoriasis (insert product form)”.
`(b1 Indications. The labeling of the
`product states, under the heading
`“indications.” the phrase listed in
`paragraph (b1(11 of this section and may
`contain any of the terms listed in'
`paragraph (b1(21 or (131(3) of this section.
`Other truthful and nonmisleading
`statements. describing only the
`indications for use that have been
`established and listed in paragraph (111
`of this section. may also be used, as
`. provided in § 330.1(c1(21 of this chapter.
`subject to the provisions of section 502
`of the Federal Food, Drug. and Cosmetic
`Act (the act) relating to misbranding and
`. the prohibition'in section 301!d) of the
`act against the introduction or delivery
`. for introduction into interstate
`
`
`
`
`
`
`
`
`UN T.4'.V4'.R AIXH R T 1061
`
`
`
`
`
` UN
`T.4'.V4'.R VS. PROCTOR & GAMBLE
`
`000001
`
`
`IIPR20l3-00509
`
`000001
`
`UNILEVER EXHIBIT 1061
`UNILEVER VS. PROCTOR & GAMBLE
`IPR2013-00509
`
`
`.
`63568 = Federal Register /‘Vol. 55, No. 233 / 9Wedn'esday, December .41, 1991 / Rules andRegu-lations'
`W
`Authority: Secs. 201. 801. 501, 502 503. 505.
`506.507.5127516. 520. 001(3). 701. 704 705. 706
`of the Federal Food, Drug. and Cosmetic Act
`(21 U5.0 321. 331. 351. 352. 353. 355. 350. W357
`360b—360f. 3601'. 361(a).-37'1. 3‘74, 375. 376);
`secs. 215, 301. 302(8). 351. 354—36017 of the
`Public Health Service Act (42 USC. 216. 241.
`242(8). 262. 263b—263n).
`»
`'.2 Section 310.545 is amendedin
`, paragraph (111(7) by removing the entry
`.“Methdl” including the parenthetical
`:' statement and alphabetically adding the
`' entry “Menthol”, by revising the ,
`,
`,' introductory text of paragraph (d1. and
`by adding paragraph [d1(31 toread as
`' follows:
`,
`.
`' § 310.565 Drug products contalning
`certain active Ingredientsoffered over-the-
`Ii
`t
`1
`IV
`‘0
`i
`- counter (OTC-1 for certain uses.
`
`Subpart Gefnesewed]
`
`"Subpart Hébrug Products for the
`Control of Dandruff. Seborrheic .
`Dermatitis, and Psoriasis
`
`‘
`
`p
`‘
`§ 358.701 Scope.
`' (a) An over-the—counter dandruff.
`V seborrheic dermatitis. or psoriasis drug
`product111 a form suitable for topical
`application'is generally recognized as
`safe and effective and1,5 not misbranded
`if it meets each of the conditions'111 this -
`,' subpartand each general condition
`established1n:§ 330.1 of this chapter. I
`'
`(b1 References'111 this subpart to
`regulatory sections of the Code of
`Federal Regulations are to chapter 1 of
`title 21 unless otherwise noted.
`(5 358.703 Definitions.
`As used in thissubpart:
`(a) 0001 tar. .The tar used for
`medicinal purposes that'is obtained as a
`byproduct during the destructive
`distillation of bituminous coal, at
`temperatures in the range of 900 “C to
`1100 °C. It may be further processed
`using either extraction with alcohol and
`= suitable dispersing agents and.
`‘ maceration times or fractional
`‘ distillation with or without the use of
`suitable organic solvents.
`(b1 Dandruff. A condition involving an
`increased rate of shedding of dead
`epidermal cells of the scalp.
`(1:) Psoriasis. A condition of the soalp
`’ or body characterized by irritation,
`itching. redness. and extreme excess
`shedding of dead epidermal cells.
`((11 Seborrheic dermatitis. A condition
`of the scalp or body characterized by
`irritation. itching. redness, and excess
`shedding of dead epidermal cells.
`
`§ 358.710 Active ingredients for the
`control of dandruff, seborrhelc dermatitis.
`or psoriasis.
`
`The active ingredient of the product
`consists of any of the following within
`the specified concentration established
`for each ingredient:
`(31111317119 ingredients for the control
`of dandruff (11 Goal tar, 0.5 to 5 percent.
`When a coal tar solution. derivative. or
`fraction is used as the source of the coal
`tor. the labeling shall specify the
`identity and concentration of the coal
`tar source used and the concentration of
`the coal tar present in the final product.
`(2) Pyrithione zinc. 0.3 to 2 percent
`when formulated to be applied and then
`washed off after brief exposure.
`(31 Pyrithione zinc. 0.1 to 0.25 percent
`when formulated to be applied and left
`on the skin or scalp.
`(4) Salicylic acid? 18 to 3 percent.
`(5) Selenium sulfide, 1 percent.
`(61 Sulfur. Z to 5 percent.
`'
`
`.
`
`‘
`
`-
`
`_
`
`'
`
`(d) Any OTC drug produCt that'13 not
`in compliance with this section18
`.
`'
`' Subject to regulatory action if initially
`introduced or initially delivered for
`' introduction into interstate commerce
`' after the dates specifiedin paragraphs .
`i
`h
`((118.1. (d1(21. and (d1(31 of this section.
`1(3) December 4, 1992, for products "
`subject to paragraph (111(7) of this
`section that contain menthol as an
`antipruritic in combination with the
`antidandruff ingredient coal tar
`_ identified1n § 358.710Ea1(11 of this
`chapter.
`
`"
`
`PART SSE—MESCELLANEOUS
`
`EXTERNIRL DRUG snooocrs FOR
`OVER-THE—CGUNTER HUMAN U35
`
`3. The authority‘citation for 21 CFR
`part 358 continues to read as follows:
`11111111111131: Secs. 201, 501, 502. 503, 505. 510.
`701 of the Federal Food. Dragons] Cosmetic
`—Act (21 USE. 321. 351. 352. 353. 355. 360, 3'71).
`
`4. Subpart G is reserved and new
`subp‘art H. consisting of §§ 358.701
`through 358.750. is added to read as
`followe:
`Subpart o~rneservec1 '
`
`Support i-i-Drug Products for the Control
`oi'Dandrutf, Seborrhelc Dermatitis, and
`Psoriasis
`. Sec.
`' 358.701 Scope.
`3.58.703 Definitions.
`358.710 Active ingredients for the control of
`dandruff, seborrheic dermatitis. or
`psoriasis.
`358.720 Permitted combinations of active
`ingredients
`358.750 Labeling of drug products for the
`control of- dandruff sebo‘rrheic
`dermatitis. for psoriasis.
`
`I
`
`(b1 Active ingredients for the control
`ofseborrbeic dermatitis. (1) Coal tar. 0.5
`to 5 percent. When a coal tar solution.
`derivative. or fractionis used as the _
`source of the coal tar. the labeling shall
`specify the identity and concentration c.
`the coal tar source used and the
`
`concentration of the coal tar present1n
`the .final product
`(21 Pyrithione zinc, 0.95 to 2 percent
`when formulatedto be applied and then ,_ .
`washed Off after brief exposure.
`.
`[31 Pyrithione zinc. 0.1 to. 0.25 percent
`when formulated to be appliedand left
`on the skin or scalp.
`(4] Salicylic acid. 1.8 to 3 percent.
`(51 Selenium sulfide. 1 percent.
`(c1 Active ingredients for the con trol-
`ofpsoriasis. (1) Coal tar, 0.5 to 5 percent.
`When a coal tar solution. derivative, or
`fraction is used as the source of the coal
`tar, the labeling shall specify the
`identity'and concentration of the coal
`tar source used and the concentration of
`the coal tar present in the final product.
`p
`(21 Salicylic acid, 1.8103 percent.
`§ 358.720 Permitted combinations '91
`active ingredients.
`.
`
`Salicylic acid identified'in § 358.710(a1
`(41 may be combined with sulfur
`identified'in § 358.710(a1(6) provided .
`each ingredient13 present within the
`established concentration and the
`product is labeled for the control of
`dandruff.
`
`\
`
`§ 358.750 Labeling of drug products tor
`the control of dandruff, seborrheic
`dermatitis. or psoriasis.
`
`(a1 Statement of identity. The labeling
`of the product contains the established
`name of the drug. if any, and identifies
`the product with one or more of the
`following. as appropriate:
`(11 “Dandruff (insert product form1" or
`“'antidandruff_(insert product form)".
`(21 “Seborrheic dermatitis {insert
`product form)".
`(31 “Psoriasis (insert product form)”.
`(b1 Indications. The labeling of the
`product states, under the heading
`“indications.” the phrase listed in
`paragraph (b1(11 of this section and may
`contain any of the terms listed in'
`paragraph (b1(21 or (131(3) of this section.
`Other truthful and nonmisleading
`statements. describing only the
`indications for use that have been
`established and listed in paragraph (111
`of this section. may also be used, as
`. provided in § 330.1(c1(21 of this chapter.
`subject to the provisions of section 502
`of the Federal Food, Drug. and Cosmetic
`Act (the act) relating to misbranding and
`. the prohibition'in section 301!d) of the
`act against the introduction or delivery
`. for introduction into interstate
`
`
`
`
`
`
`
`
`UN T.4'.V4'.R AIXH R T 1061
`
`
`
`
`
` UN
`T.4'.V4'.R VS. PROCTOR & GAMBLE
`
`000001
`
`
`IIPR20l3-00509
`
`000001
`
`UNILEVER EXHIBIT 1061
`UNILEVER VS. PROCTOR & GAMBLE
`IPR2013-00509
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
