DRUG FACTS

ISOMERS CLEAR SKIN ACNE TREATMENT GEL - salicylic acid gel
Isomers Laboratories Inc

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

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ACTIVE INGREDIENT

Salicylic Acid 2%

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STOP USE AND ASK DOCTOR

IF IRRITATION BECOMES SEVERE

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KEEP OUT OF REACH OF CHILDREN

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PURPOSE

ACNE TREATMENT

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WARNINGS

For External Use Only
Keep away from eyes
Using other topical medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin, if this occurs only one medication should be used
In case of accidental ingestion seek professional advice or contact a poison control center immediately

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INACTIVE INGREDIENTS

Purified Water, Propylene Glycol, Optunia Ficus indica Stem Extract, Boerhavia Diffusa Root Extract, Thermus Thermophilus Ferment, Glycerin, Pentylene Glycol, Zinc PCA, Hydroxyethyl Cellulose, Phenoxyethanol, Decylene Glycol, Sodium Stearoyl Lactate, Sodium Hydroxide

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image of product label

ISOMERS CLEAR SKIN ACNE TREATMENT GEL
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64990-601
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.02 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Hydroxide (UNII: 55X04QC32I)
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64990-601-01	60 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	12/26/2009

Labeler - Isomers Laboratories Inc (253306799)

Registrant - Isomers Laboratories Inc (253306799)

Name	Address	ID/FEI	Business Operations
Establishment
Isomers Laboratories Inc		253306799	manufacture