LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT- benzoyl peroxide lotion

La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment by is a Otc medication manufactured, distributed, or labeled by L'OREAL USA, INC., Beauty Manufacturing Solutions Corp., L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Questions or comments?

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

Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-076
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-076-01	1 in 1 CARTON	07/01/2012
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-076-02	1 in 1 CARTON	07/01/2012
2		20 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-076-03	3 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(49967-076)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-076)