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

La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, COSMETIQUE ACTIVE PRODUCTION. 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

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product 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 Drug	M006	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)