Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUEEFFACLAR DUO - benzoyl peroxide lotion 
L'OREAL USA, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Benzoyl peroxide 5.5%

Purpose

Acne medication

Uses

• for the treatment of acne
• dries and clears acne 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

• 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 prdoucts and ask a doctor.
  

Other information

store at 20 - 25 C (68 to 77 F)

Inactive ingredients

water, isostearyl alcohol, glycerin, pentylene glycol, silica, carbomer, capryloyl salicylic acid, potassium hydroxide, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, epilobium angustifolium flower/leaf/stem extract

Keep out of reach of children.

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

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUEEFFACLAR DUO  
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl peroxide (UNII: W9WZN9A0GM) (Benzoyl peroxide - UNII:W9WZN9A0GM)	Benzoyl peroxide	55 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-075-01	1 in 1 CARTON	07/01/2012	07/21/2018
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 final	part333D	07/01/2012	07/21/2018

Labeler - L'OREAL USA, INC. (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Coats Aloe International, Inc.		783712987	manufacture(49967-075)

Revised: 9/2019

Document Id: bff494b8-3d9c-4f9c-aa85-f62e6fa85679

34390-5

Set id: 6cdd0ab1-d30f-40d3-bf3a-5d7d178b1d31

Version: 7

Effective Time: 20190912