LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT- 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

Warnings

For external use only

Do not use if you

When using this product

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

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)

image of a carton

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl peroxide (UNII: W9WZN9A0GM) (Benzoyl peroxide - UNII:W9WZN9A0GM) Benzoyl peroxide55 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-076-011 in 1 CARTON07/01/2012
140 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-076-021 in 1 CARTON07/01/2012
220 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:49967-076-033 mL in 1 PACKET; Type 0: Not a Combination Product07/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/01/2012
Labeler - L'OREAL USA, INC. (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723manufacture(49967-076) , pack(49967-076)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458analysis(49967-076)

Revised: 9/2020
Document Id: 9db596bc-e66e-4ed1-b8e8-33ceb3e99d00
Set id: 8ed6ee51-816e-4c83-a437-4ceaa339b130
Version: 7
Effective Time: 20200902
 
L'OREAL USA, INC.