LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR ANTIACNE PORE REFINING ACNE TREATMENT- salicylic acid liquid

La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment by is a Otc medication manufactured, distributed, or labeled by COSMETIQUE ACTIVE PRODUCTION, Interspray. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Uses

• clears acne blemishes
• penetrates pores to control acne blemishes
• helps prevent new acne blemishes from forming

Warnings

For external use only

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

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

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR ANTIACNE PORE REFINING ACNE TREATMENT 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69625-528
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: 69625-528-01	1 in 1 CARTON	05/01/2022
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 69625-528-02	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 Drug	M006	05/01/2022

Labeler - COSMETIQUE ACTIVE PRODUCTION (282658798)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIQUE ACTIVE PRODUCTION		282658798	manufacture(69625-528) , pack(69625-528)

Establishment
Name	Address	ID/FEI	Business Operations
Interspray		364829903	pack(69625-528)