`
`
`JUBLIA™ (joo-blee-uh)
`
`
`(efinaconazole)
`
`
`topical solution, 10%
`
`
`
`
` Important information: JUBLIA is for use on toenails and surrounding skin only. Do not
`
`
` use JUBLIA in your mouth, eyes or vagina.
`
`
`
`
`
`
`Read this Instructions for Use that comes with JUBLIA before you start using it. Talk to your
`
`healthcare provider if you have any questions.
`
`How to apply JUBLIA:
`
`
`Your toenails should be clean and dry before you apply JUBLIA.
`
`
`
`
`Step 1: Remove the cap from the JUBLIA bottle.
`
`
`
`
`Step 2: Hold the bottle upside down directly over the affected toenail.
`
`
`
`
` By turning the bottle upside down, the entire brush will
` become moistened with the solution.
`
`
`
`
`
`
` Apply one drop of JUBLIA onto the toenail.
`Do not squeeze the bottle, or press or rub the brush firmly
`
`
`
`
`
`
`
` against the toenail while applying JUBLIA.
`
`
`
`
`Step 3: For the big toenail, also apply a second drop to the end of the
`
`
`
`
`
` toenail using the tip of the brush.
`
`
` If needed, repeat Step 2 to re-wet the brush.
`
`
`
`
`
`Step 4: Use the brush to gently spread JUBLIA around the entire
`
`
`
`
`
`
` toenail, including the cuticle, folds of the skin next to the sides
`
`
` of the toenail, and underneath the nail.
`
`
`
`Do not squeeze the bottle, or press or rub the brush firmly
`
`
`
`
`
` against the toenail while spreading JUBLIA with the brush.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Step 5: Repeat Steps 2 to 4 to apply JUBLIA to each affected toenail.
`
`
`
`
`
`
`
`Step 6: Let JUBLIA dry completely.
`
`
`Step 7: After applying JUBLIA to your affected toenails, place the cap on the bottle and screw it
`
`
`on tightly.
`
`Step 8: Wash your hands with soap and water after applying JUBLIA.
`
`
`
`Reference ID: 3988691
`
`
`
`
`
`
`This Instructions for Use has been approved by the U.S. Food and Drug Administration.
`
`
`
`Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA
`
`
`
`
`Manufactured by: Valeant Pharmaceuticals International, Inc., Laval, Quebec H7L 4A8, Canada
`
`
`
`
`
`Revised: 09/2016
`
`9462901
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3988691
`
`
`
`
`
`Instructions for Use
`
`
`JUBLIA™ (joo-blee-uh)
`
`
`(efinaconazole)
`
`
`topical solution, 10%
`
`
`
`
` Important information: JUBLIA is for use on toenails and surrounding skin only. Do not
`
`
` use JUBLIA in your mouth, eyes or vagina.
`
`
`
`
`
`
`Read this Instructions for Use that comes with JUBLIA before you start using it. Talk to your
`
`healthcare provider if you have any questions.
`
`How to apply JUBLIA:
`
`
`Your toenails should be clean and dry before you apply JUBLIA.
`
`
`
`
`Step 1: Remove the cap from the JUBLIA bottle.
`
`
`
`
`Step 2: Hold the bottle upside down directly over the affected toenail.
`
`
`
`
` By turning the bottle upside down, the entire brush will
` become moistened with the solution.
`
`
`
`
`
`
` Apply one drop of JUBLIA onto the toenail.
`Do not squeeze the bottle, or press or rub the brush firmly
`
`
`
`
`
`
`
` against the toenail while applying JUBLIA.
`
`
`
`
`Step 3: For the big toenail, also apply a second drop to the end of the
`
`
`
`
`
` toenail using the tip of the brush.
`
`
` If needed, repeat Step 2 to re-wet the brush.
`
`
`
`
`
`Step 4: Use the brush to gently spread JUBLIA around the entire
`
`
`
`
`
`
` toenail, including the cuticle, folds of the skin next to the sides
`
`
` of the toenail, and underneath the nail.
`
`
`
`Do not squeeze the bottle, or press or rub the brush firmly
`
`
`
`
`
` against the toenail while spreading JUBLIA with the brush.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Step 5: Repeat Steps 2 to 4 to apply JUBLIA to each affected toenail.
`
`
`
`
`
`
`
`Step 6: Let JUBLIA dry completely.
`
`
`Step 7: After applying JUBLIA to your affected toenails, place the cap on the bottle and screw it
`
`
`on tightly.
`
`Step 8: Wash your hands with soap and water after applying JUBLIA.
`
`
`
`Reference ID: 3988691
`
`
`
`
`
`
`This Instructions for Use has been approved by the U.S. Food and Drug Administration.
`
`
`
`Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA
`
`
`
`
`Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan
`
`
`
`
`
`Revised: 09/2016
`
`9391903
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3988691
`
`
`
`
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