CLEAR SKIN ACNE TREATMENT CLEANSER- salicylic acid solution 
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


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ACTIVE INGREDIENT

Salicylic Acid    2%

Acne Mediciation

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

For external use only

When usiong 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.

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KEEP OUT OF REACH OF CHILDREN.

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

  • wet face
  • dispense products into hands and massage gently onto face and neck, avoiding the delicate eye area
  • cover the entire affected area with thin layer and rinse thoroughly with warm water one to three times daily
  • because excessive drying of the skin may occur, start with one application daily,then gradually increase to two ot three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

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INACTIVE INGREDIENTS

Purified Water, Sodium Lauryl Glucose Carboxylate, Lauryl Glucoside, Coco Betaine, Coco-Glucoside, Glyceryl Oleate, Sodium Chloride, Sodium Citrate, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid.

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CLEAR SKIN ACNE TREATMENT CLEANSER 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-609
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)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sorbic Acid (UNII: X045WJ989B)  
Sodium Chloride (UNII: 451W47IQ8X)  
Lauryl Glucoside (UNII: 76LN7P7UCU)  
Glyceryl Oleate (UNII: 4PC054V79P)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64990-609-11240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/201912/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/25/201312/22/2022
Labeler - Isomers Laboratories Inc. (253306799)
Registrant - Isomers Laboratories Inc. (253306799)
Establishment
NameAddressID/FEIBusiness Operations
Isomers Laboratories Inc.253306799manufacture(64990-609)

Revised: 12/2022
 
Isomers Laboratories Inc.