BPO - benzoyl peroxide gel 
Acella Pharmaceuticals, LLC

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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BPO 8% Gel

Active Ingredient

Benzoyl Peroxide 8%

Purpose

Acne Medication

Use treats acne and helps prevent new acne blemishes from forming

Keep out of reach of children.

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

Warning

For external use only.

Do not use

if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

When using this product

  • avoid unnecessary sun exposure and use sunscreen
  • keep away from eyes, lips and mouth
  • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate such irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
  • 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.

Stop use and ask doctor if

irritation becomes severe.

Direction

  • 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 nay occur, start with one application daily, then gradually increase to two or three times daily
  • if needed or as directed by a doctorif bothersome dryness or peeling ocurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develpos, discontinue use of product and consult a doctor

Inactive Ingredients

aloe barbadebsis leaf juice, benzyl alcohol, ceteareth-20, cetyl alcohol, dimethyl isisirbide, purified water, simethicone and stearyl alcohol.

Tube

U Carton

BPO  
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42192-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide8 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42192-106-1612 in 1 PACKAGE01/01/200902/29/2020
11 in 1 CARTON
142500 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/200902/29/2020
Labeler - Acella Pharmaceuticals, LLC (825380939)
Registrant - Ei Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Ei Inc.105803274manufacture(42192-106) , label(42192-106) , pack(42192-106)

Revised: 9/2023
 
Acella Pharmaceuticals, LLC