ISOMERS CLEAR SKIN ACNE SPOT TREATMENT- salicylic acid gel

Isomers Clear Skin Acne Spot Treatment by

Drug Labeling and Warnings

Isomers Clear Skin Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Isomers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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Active Ingredient:

Salicylic Acid         2%

PURPOSE

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Purpose:

Acne Treatment

ASK DOCTOR

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Stop use and ask doctor

If irritation becomes severe

KEEP OUT OF REACH OF CHILDREN

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Keep out of reach of children

WARNINGS

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Warnings :

• For external use only
• Keep away from eyes
• Using other topical acne 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 assistance or contact a poison control center immediately
  

INACTIVE INGREDIENT

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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 Lacylate, Sodium Hydroxide.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ISOMERS CLEAR SKIN ACNE SPOT TREATMENT  
salicylic acid gel

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

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64990-601-04	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/01/2010

Labeler - Isomers Laboratories Inc (253306799)

Registrant - Isomers Laboratories Inc (253306799)

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