Isomers Clear Skin Acne Treatment Gel: Package Insert and Label Information

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.

ACTIVE INGREDIENT

SALICYLIC ACID 2%

PURPOSE

ACNE TREATMENT

STOP USE AND ASK DOCTOR

IF IRRITATION BECOMES SEVERE

KEEP OUT OF REACH OF CHILDREN

WARNING:

  • 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 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 Lactylate, Sodium Hydroxide.

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.02 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
OPUNTIA FICUS-INDICA
GLYCERIN
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
PHENOXYETHANOL
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64990-601-03 240 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 12/28/2009
Labeler — Isomers Laboratories Inc (253306799)
Registrant — Isomers Laboratories Inc (253306799)
Establishment
Name Address ID/FEI Operations
Isomers Laboratories Inc 253306799 manufacture

Revised: 02/2010 Isomers Laboratories Inc

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