LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO PLUS M MULTI TARGET ACNE TREATMENT- salicylic acid liquid

La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment by is a Otc medication manufactured, distributed, or labeled by COSMETIQUE ACTIVE PRODUCTION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 0.5%

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

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

• 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.

Inactive ingredients

water, glycerin, dimethicone, isocetyl stearate, niacinamide, isopropyl lauroyl sarcosinate, silica, ammonium polyacryloyldimethyl taurate, oryza sativa (rice) starch, punica granatum pericarp extract, potassium cetyl phosphate, sorbitan oleate, zinc PCA, glyceryl stearate SE, isohexadecane, sodium hydroxide, myristyl myristate, 2-oleamido-1,3-octadecanediol, mannose, poloxamer 338, propanediol, hydroxyethoxyphenyl butanone, capryloyl salicylic acid, caprylyl glycol, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, maltodextrin, xanthan gum, pentylene glycol, polysorbate 80, acrylamide/sodium acryloyldimethyltaurate copolymer, piroctone olamine, fragrance

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO PLUS M MULTI TARGET ACNE TREATMENT 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69625-926
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
ORYZA SATIVA (RICE) STARCH (UNII: 4DGK8B7I3S)
POMEGRANATE FRUIT RIND (UNII: RS999V57DU)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SORBITAN OLEATE (UNII: 06XEA2VD56)
ZINC PCA (UNII: C32PQ86DH4)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOHEXADECANE (UNII: 918X1OUF1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
2-OLEAMIDO-1,3-OCTADECANEDIOL (UNII: 30D478BUNR)
MANNOSE (UNII: PHA4727WTP)
POLOXAMER 338 (UNII: F75JV2T505)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYETHOXYPHENYL BUTANONE (UNII: TH7XI54W45)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
VITREOSCILLA LYSATE (UNII: 68DV8T89Y2)
CITRIC ACID (UNII: 2968PHW8QP)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%) (UNII: 5F4963KLHS)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69625-926-01	1 in 1 CARTON	05/14/2025
1		40 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	05/14/2025

Labeler - COSMETIQUE ACTIVE PRODUCTION (282658798)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIQUE ACTIVE PRODUCTION		282658798	manufacture(69625-926)