Label: VIVANT BP10% GEL MEDICATION- benzoyl peroxide gel
- NDC Code(s): 63750-005-30
- Packager: Vivant Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 7, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Use
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Warnings
For external use only
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.
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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
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VIVANT BP10% GEL MEDICATION
benzoyl peroxide gelProduct 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)
