LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR AZ ACNE TREATMENT- salicylic acid cream

La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Effaclar AZ 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 1.2%

Purpose

Acne treatment

Uses

• for the treatment of acne
• clears acne blemishes
• penetrates pores to control acne blemishes
• helps prevent new acne blemishes from forming

Warnings

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

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

Directions

• shake well before use
• 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
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

• store at room temperature 68⁰ – 77⁰F
• protect from freezing

Inactive ingredients

water, azelaic acid, C15-19 alkane, glycerin, triethyl citrate, diglycerin, panthenol, silica, ammonium polyacryloyldimethyl taurate, taraxacum officinale (dandelion) rhizome/root extract, zinc gluconate, glyceryl stearate, PEG-100 stearate, sodium hyaluronate, sodium hydroxide, sodium phosphate, disodium phosphate, hydroxyethylcellulose, hydroxypropyl starch phosphate, tetrasodium glutamate diacetate, citric acid, trisodium ethylenediamine disuccinate, pentylene glycol, polysorbate 60, fragrance

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR AZ ACNE TREATMENT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-735
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AZELAIC ACID (UNII: F2VW3D43YT)
C15-19 ALKANE (UNII: CI87N1IM01)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
DIGLYCERIN (UNII: 3YC120743U)
PANTHENOL (UNII: WV9CM0O67Z)
SILICA (UNII: ETJ7Z6XBU4)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE (UNII: SE337SVY37)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CITRIC ACID (UNII: 2968PHW8QP)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-735-01	1 in 1 CARTON	06/12/2025
1		40 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 49967-735-02	1 in 1 CARTON	06/12/2025
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	06/12/2025

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIQUE ACTIVE PRODUCTION		282658798	manufacture(49967-735)