Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR PORE REFINING ACNE TREATMENT- salicylic acid liquid
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- NDC Code(s): 49967-529-01, 49967-529-02
- Packager: L'Oreal USA Products Inc
- 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 21, 2023
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- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children.
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Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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
- children under 12 years of age: ask a doctor
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Inactive ingredients
water, alcohol denat., propanediol, glycolic acid, niacinamide, dimethyl isosorbide, pentylene glycol, sodium hydroxide, capitolize-26-buteth-26, PPG-26-buteth-26, hydroxyethylpiperazine ethane sulfonic acid, citric acid, PEG-30 glyceryl cocoate, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, capryloyl salicylic acid, biosaccharide gum-1, maltodextrin, phytic acid, polyquaternium-10, fragrance
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR PORE REFINING ACNE TREATMENT
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-529 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPANEDIOL (UNII: 5965N8W85T) GLYCOLIC ACID (UNII: 0WT12SX38S) NIACINAMIDE (UNII: 25X51I8RD4) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) PENTYLENE GLYCOL (UNII: 50C1307PZG) SODIUM HYDROXIDE (UNII: 55X04QC32I) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PEG-30 GLYCERYL COCOATE (UNII: FX3EB7VC3L) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) MALTODEXTRIN (UNII: 7CVR7L4A2D) FYTIC ACID (UNII: 7IGF0S7R8I) POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-529-01 1 in 1 CARTON 05/01/2022 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:49967-529-02 1 in 1 CARTON 05/01/2022 2 3 mL 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 05/01/2022 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations COSMETIQUE ACTIVE PRODUCTION 282658798 manufacture(49967-529) , pack(49967-529) Establishment Name Address ID/FEI Business Operations Interspray 364829903 pack(49967-529)
