ISOMERS CLEAR SKIN ACNE TREATMENT LOTION- salicylic acid lotion

Isomers Clear Skin Acne Treatment Lotion by

Drug Labeling and Warnings

Isomers Clear Skin Acne Treatment Lotion 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

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 help or contact a poison control center immediately
  

INACTIVE INGREDIENT

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Inactive ingredients:

Purified water, Cetearyl Alcohol, Ceteth 20 Phosphate, Dicetyl Phosphate, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, C 10-30 Cholesterol Lanosterol Esters, Optunia Ficus Indica stem Extract, Boerhavia Diffusa Root Extract, Thermus Thermophilus Ferment, Pentylene Glycol, Phenoxyethanol, Tropolone, Decylene Glycol, C 20-40 Pareth 10, Zinc PCA, Sodium Hydroxide.

PRINCIPAL DISPLAY PANEL

CSATL240.jpg

INGREDIENTS AND APPEARANCE

ISOMERS CLEAR SKIN ACNE TREATMENT LOTION 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64990-605
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)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64990-605-07	240 mL in 1 BOTTLE

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

Labeler - Isomers Laboratories Inc (253306799)

Registrant - Isomers Laboratories Inc (253306799)

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