VIVANT BP10% GEL MEDICATION- benzoyl peroxide gel

Vivant BP10% Gel Medication by

Drug Labeling and Warnings

Vivant BP10% Gel Medication by is a Otc medication manufactured, distributed, or labeled by Vivant Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 3%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use

if you

have very sensitive skin
are sensitive to benzoyl peroxide

When using this product

• 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.

Stop use and ask a doctor if

irritation becomes severe

Keep out of reach of children.

If a product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flus thoroughly with water.

Directions

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 to three times daily if needed or as directed by the 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 using this product and ask a

doctor.

Inactive Ingredients

Inactive Ingredients: Water, Ammonium Lauryl Sulfate, Glycerin, Propylene Glycol, Disodium Cocoamphodiacetate, Carbomer, Sodium Hydroxide

Other Information

Other Information
■ Keep tightly closed. Avoid storing at temperatures above 90°F.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VIVANT BP10% GEL MEDICATION 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63750-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63750-005-30	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/01/2024

Labeler - Vivant Pharmaceuticals, LLC (782696814)

Establishment
Name	Address	ID/FEI	Business Operations
Vivant Pharmaceuticals, LLC		782696814	manufacture(63750-005)