CLEAR SKIN ACNE TREATMENT - 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.

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DRUG FACTS


ACTIVE INGREDIENT:

SALICYLIC ACID 2% W/W

PURPOSE:

ACNE medication

  • for the treatment of acne
  • dries up acne pimples
  • helps prevent new acne pimples

For external use only.

When using this product

  • avoid contact with eyes.If product gets into the eyes rinse thoroughly with water
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.If irritation occurs, only use one topical acne medication at a time
  • limit use to the face and neck

Stop use and see a doctor If skin and eye irritation develops.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS:

PURIFIED WATER, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, PROPYLENE GLYCOL, CETETH-20 PHOSPHATE, DICETYL PHOSPHATE, PHENOXYETHANOL, C20-40 PARETH-10, TROPOLONE, SODIUM HYDROXIDE.

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur,start with one application daily,then gradually increase to two or three times daily if neede or as directed by a doctor
  • If bothersome dryness or peeling occurs,reduce application to once a day or every other day.

IMAGE OF PRODUCT LABEL

IMAGE OF PRODUCT LABEL

MM10

IMAGE OF PRODUCT LABEL

CLEAR SKIN ACNE TREATMENT  
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cetyl Alcohol (UNII: 936JST6JCN)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)  
C20-40 Pareth-10 (UNII: TE3MZI4V3F)  
Tropolone (UNII: 7L6DL16P1T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64990-610-10120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/201912/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/27/201212/22/2022
Labeler - Isomers Laboratories Inc. (253306799)
Registrant - Isomers Laboratories Inc. (253306799)
Establishment
NameAddressID/FEIBusiness Operations
Isomers Laboratories Inc.253306799manufacture(64990-610)

Revised: 12/2022
 
Isomers Laboratories Inc.