Label: PHISODERM ANTI-BLEMISH GEL CLEANSER- salicylic acid gel
- NDC Code(s): 10742-8417-1
- Packager: The Mentholatum Company
- 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 February 7, 2023
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
- Keep Out of Reach of Children
- Directions
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Inactive ingredients
water, lauramidopropyl betaine, sodium C14-16 olefin sulfonate, lauryl glucoside, trolamine, butylene glycol, chamomilla recutita (matricaria) flower extract, disodium EDTA, DMDM hydantoin, fragrance, glycerin, hydroxyphenyl propamidobenzoic acid, iodopropynyl butylcarbamate, lactic acid, pentylene glycol, polysorbate 20, sodium chloride
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INGREDIENTS AND APPEARANCE
PHISODERM ANTI-BLEMISH GEL CLEANSER
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8417 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) TROLAMINE (UNII: 9O3K93S3TK) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CHAMOMILE (UNII: FGL3685T2X) EDETATE DISODIUM (UNII: 7FLD91C86K) DMDM HYDANTOIN (UNII: BYR0546TOW) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) PENTYLENE GLYCOL (UNII: 50C1307PZG) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8417-1 177 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/01/2013 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-8417)