Label: MEDICATED ACNE SHOWER- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58876-108-30 - Packager: DR LIN SKINCARE
- 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 July 11, 2014
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDICATED ACNE SHOWER
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58876-108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58876-108-30 295 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/13/2013 Labeler - DR LIN SKINCARE (622329980) Establishment Name Address ID/FEI Business Operations Westwood Laboratories Inc. 069926483 manufacture(58876-108) , pack(58876-108)