VIVANT BP10% GEL MEDICATION- benzoyl peroxide gel 
Vivant Pharmaceuticals, LLC

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Vivant BP10% Gel Medication

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.

label

VIVANT BP10% GEL MEDICATION 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63750-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63750-005-3030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00602/01/2024
Labeler - Vivant Pharmaceuticals, LLC (782696814)
Establishment
NameAddressID/FEIBusiness Operations
Vivant Pharmaceuticals, LLC782696814manufacture(63750-005)

Revised: 2/2024
Document Id: 10cc6d4c-592f-5420-e063-6294a90a137d
Set id: 10cc63b8-b4f9-6a78-e063-6294a90aade4
Version: 1
Effective Time: 20240207
 
Vivant Pharmaceuticals, LLC