LA ROCHE-POSAY EFFACLAR DUO DUAL ACTION ACNE TREATMENT- benzoyl peroxide lotion

La Roche-Posay Effaclar Duo Dual Action Acne Treatment by

Drug Labeling and Warnings

La Roche-Posay Effaclar Duo Dual Action Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Beauty Manufacturing Solutions Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzoyl Peroxide 5.5%

Purpose Ance Medication

PURPOSE

Acne medication

INDICATIONS & USAGE

• for the treatment of acne
• dries and clears acne blemishes and allows skin to heal

WARNINGS

For external use only

DO NOT USE

• have very sensitive skin
• are sensitive to benzoyl peroxide

WHEN USING

• 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

irritation becomes severe

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• 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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

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

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE-POSAY EFFACLAR DUO DUAL ACTION ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-223
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
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
WATER (UNII: 059QF0KO0R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
PENTYLENE GLYCOL (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-223-01	20 in 1 CARTON	07/01/2012
1		3 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-223-02	1 in 1 CARTON	07/01/2012
2		20 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-223-03	1 in 1 CARTON	07/01/2012
3		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

Labeler - Beauty Manufacturing Solutions Corp (783200723)

Registrant - Beauty Manufacturing Solutions Corp (783200723)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp		783200723	manufacture(11090-223)