LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPO- benzoyl peroxide cream

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 5.5%

Purpose

Acne treatment

Uses

• for the treatment of acne
• clears acne blemishes
• penetrates pores to control acne blemishes
• helps prevent new acne blemishes from forming

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 mayoccur, start with one application daily, thengradually increase to two or three timesdaily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs,reduce application to once a day or everyother day
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

• store at room temperature 68°-77°F

Inactive ingredients

water, glycerin, pentylene glycol, carbomer, silica, tocopheryl acetate, sodium citrate, sodium hydroxide, sodium metabisulfite, diethylhexyl sodium sulfosuccinate, phenoxyethanol, epilobium angustifolium flower/leaf/stem extract, propanediol, acrylates/C10-30 alkyl acrylate
crosspolymer, disodium EDTA, potassium hydroxide

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 BENZOYL PEROXIDE EFFACLAR BPO 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-884
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)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CARBOMER (UNII: 0A5MM307FC)
SILICA (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
DIETHYLHEXYL SODIUM SULFOSUCCINATE (UNII: F05Q2T2JA0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
PROPANEDIOL (UNII: 5965N8W85T)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-884-01	1 in 1 CARTON	05/22/2026
1		20 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82046-884-02	15 in 1 CARTON	05/22/2026
2		3 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82046-884-03	1 in 1 CARTON	05/22/2026
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 Drug	M006	05/22/2026

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(82046-884)