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

ISOMERS CLEAR SKIN ACNE TREATMENT LOTION — salicylic acid lotion
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

Enter section text here

Stop use and ask doctor

Irritation becomes Severe

Keep out of reach of children

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 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.

CSATL240.jpg

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 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 CETOSTEARYL ALCOHOL DIHEXADECYL PHOSPHATE MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN CETYL ALCOHOL OPUNTIA FICUS-INDICA PHENOXYETHANOL SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64990-605-07 240 mL in 1 BOTTLE None

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

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