ACNEFREE 2-IN-1 ACNE WIPES- salicylic acid cloth
Valeant Pharmaceuticals North America LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Salicylic Acid 0.5% w/v

Purpose

Acne treatment

Use

for the treatment of acne.

Warnings

For external use only.

Do not use

•: If you have a known allergy to Salicylic Acid or aspirin.

Ask doctor or pharmacist before use

•: If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.

When using this product

•: Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Peel label to open. Unfold towelette and gently wipe over face, neck, and shoulders, as desired. No need to rinse. Avoid contact with eyes, lips, and mouth. If dryness or peeling occurs, reduce application to once a day or every other day. Reseal pack to prevent from drying. Dispose towelette in trash receptacle (do not flush).

Inactive ingredients

ammonium laureth sulfate, ammonium xylenesulfonate, glycerin, isoceteth-20, methylisothiazolinone, panthenol, phenoxyethanol, polyquaternium-7, propanediol, SD alcohol 40B, simethicone, sodium hydroxide, sodium lauroamphoacetate, tetrasodium glutamate diacetate, water

Other Information

Store at 60°-95°F (15°-35°C).

Questions or comments

1-800-321-4576

PRINCIPAL DISPLAY PANEL - 30 count pouch

AcneFree®

CLEAR SKIN TREATMENTS

2-in-1

Acne Wipes

0.5% Salicylic Acid Acne Medication

CLEANSE + TREAT

Clear Your Skin Anytime, Anywhere

30 LARGE 7” x 7 ¾”

TOWELETTES

9431902 REV 04/15

ACNEFREE 2-IN-1 ACNE WIPES
salicylic acid cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0187-1605
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5 mg

Ingredient Name	Strength
Inactive Ingredients
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
GLYCERIN (UNII: PDC6A3C0OX)
ISOCETETH-20 (UNII: O020065R7Z)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0187-1605-30	30 in 1 PACKAGE; Type 0: Not a Combination Product	11/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	11/01/2014	02/17/2017

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Revised: 2/2017

Document Id: 89ffbd61-c456-4880-b76a-ed8534957a31

Set id: 2856b11a-db64-4056-aad1-fee3b789112f

Version: 3

Effective Time: 20170217

Valeant Pharmaceuticals North America LLC