Benzoyl Peroxide by Innovida Pharmaeutique Corporation BENZOYL PEROXIDE gel

Benzoyl Peroxide by

Drug Labeling and Warnings

Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Innovida Pharmaeutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzoyl peroxide USP 10%

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 product

• avoid unnecessary sun exposure and use a sunscreen 
• avoid contact with eyes, lips and mouth 
• avoid contact with hair or 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. 
• 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 consult a doctor if· irritation becomes severe
• If pregnant or breast-feeding, ask a health professional before use.

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.

KEEP OUT OF REACH OF CHILDREN

Directions

• 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 products and ask a doctor.

Other information

• keep tightly closed 
• store at room temperature

Inactive Ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Product label

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71800-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71800-045-06	1 in 1 CARTON	02/10/2025
1		62 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/10/2025

Labeler - Innovida Pharmaeutique Corporation (080892908)