LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO DUAL ACTION ACNE MEDICATION CLEANSER- benzoyl peroxide liquid

La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication Cleanser by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication Cleanser by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Accupac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 4.0%

Purpose

Acne treatment

Uses

• for the treatment of acne
• helps clear up blemishes and allows skin to heal

Warnings

For external use only

Do not use if you

have very sensitive skin
are sensitive to benzoyl peroxide

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
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

irritation becomes severe

Keep out of reach of children.

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

Directions

apply a dime-size amount to damp skin

gently massage, avoiding the eye area

rinse well

use cleanser on entire affected area, every morning and evening

because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, potassium hydroxide, sodium chloride, sodium citrate, niacinamide, sodium hyaluronate, capryloyl salicylic acid, propanediol, diethylhexyl sodium sulfosuccinate, carbomer, benzoic acid, pentylene glycol, sodium hydroxide, glycolic acid, tetrasodium EDTA, trisodium ethylenediamine disuccinate, citric acid

Questions or comments?

1-888-LRP-LABO 1-888-577-5226

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO DUAL ACTION ACNE MEDICATION CLEANSER 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-647
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	Benzoyl peroxide	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
PROPANEDIOL (UNII: 5965N8W85T)
DIETHYLHEXYL SODIUM SULFOSUCCINATE (UNII: F05Q2T2JA0)
CARBOMER (UNII: 0A5MM307FC)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TETRASODIUM EDTA (UNII: MP1J8420LU)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-647-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	01/01/2025

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, LLC		061595175	manufacture(49967-647)