Label: KLEARACTIL- acne topical treatment gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69492-012-05, 69492-012-20 - Packager: POLIMEROS Y SERVICIOS S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 15, 2019
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- Detail showing Active Ingredient from package
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- Detail showing Dosage and Administration within Directions from package
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INGREDIENTS AND APPEARANCE
KLEARACTIL
acne topical treatment gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69492-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, L- (UNII: F9S9FFU82N) METHYLPARABEN (UNII: A2I8C7HI9T) ORTHOSILICIC ACID (UNII: 623B93YABH) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69492-012-20 1 in 1 BOX 03/04/2019 1 NDC:69492-012-05 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/29/2015 Labeler - POLIMEROS Y SERVICIOS S.A. (815740251) Establishment Name Address ID/FEI Business Operations POLIMEROS Y SERVICIOS S.A. 815740251 manufacture(69492-012)