BENZOYL PEROXIDE- benzoyl peroxide gel 
Innovida Pharmaeutique Corporation

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Active Ingredient

Benzoyl peroxide 5%

Purpose

Acne treatment

Uses

For the treatment of acne

Warnings

For external use only
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
When using this productkeep away from eyes, lips and mouth
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
• using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

Directions

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness
or peeling occurs, reduce application to once a day.

Other information

Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

Inactive Ingredients

carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water

Product label

image descriptionimage description

BENZOYL PEROXIDE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71800-043
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURETH-4 (UNII: 6HQ855798J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71800-043-041 in 1 CARTON02/10/2025
144 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00602/10/2025
Labeler - Innovida Pharmaeutique Corporation (080892908)

Revised: 2/2025
Document Id: 2efb1829-51e3-5bdf-e063-6394a90af996
Set id: 52d9f0f2-b474-427c-94aa-5ba9d6eeb9f8
Version: 1
Effective Time: 20250225
 
Innovida Pharmaeutique Corporation