Label: OIL-FREE FOAMING ACNE WASH- salicylic acid gel
- NDC Code(s): 58503-031-01
- Packager: China Ningbo Shangge Cosmetic Technology Corp,
- 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 September 12, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
Inactive Ingredients: water, sodium c14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, propylene glycol, sodium lauryl sulfate, fragrance, polyethylene glycol, sodium lauryl sulfate, fragrance, polyethylene, citric acid, aloe barbadensis leaf juice, tocopheryl acetate, disodium EDTA, sodium hydroxide, FD&C red no.33
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OIL-FREE FOAMING ACNE WASH
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 3 g in 150 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-031-01 150 g in 1 BOTTLE; Type 0: Not a Combination Product 11/18/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/18/2013 Labeler - China Ningbo Shangge Cosmetic Technology Corp, (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp, 529287434 manufacture(58503-031)