La Roche-Posay Effaclar Duo

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]

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.

----------

La Roche-Posay Effaclar Duo

Benzoyl Peroxide 5.5%

Purpose Ance Medication

Acne medication

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

For external use only

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

  • 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

irritation becomes severe

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

  • 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.

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