LA ROCHE-POSAY EFFACLAR DUO DUAL ACTION ACNE TREATMENT- benzoyl peroxide lotion 
Beauty Manufacturing Solutions Corp

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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La Roche-Posay Effaclar Duo

Benzoyl Peroxide 5.5%

Purpose Ance Medication

Acne medication

For external use only

avoid unnecessary sun exposure and use a sunscreen

irritation becomes severe

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

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

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

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

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

Principle Display Panel

Principle Display Panel

Principle Display Panel

LA ROCHE-POSAY EFFACLAR DUO DUAL ACTION ACNE TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-223
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-223-0120 in 1 CARTON07/01/2012
13 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-223-021 in 1 CARTON07/01/2012
220 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-223-031 in 1 CARTON07/01/2012
340 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/01/2012
Labeler - Beauty Manufacturing Solutions Corp (783200723)
Registrant - Beauty Manufacturing Solutions Corp (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp783200723manufacture(11090-223)

Revised: 2/2022
Document Id: d7c24ac7-e164-6907-e053-2a95a90a8d3d
Set id: c46b8737-d591-bcaa-e053-2a95a90a9fff
Version: 2
Effective Time: 20220211
 
Beauty Manufacturing Solutions Corp