Vivant Bp3% Exfoliating Cleanser Liquid
FDA Label NDC 63750-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vivant Pharmaceuticals, Llc for the product Vivant Bp3% Exfoliating Cleanser (NDC 63750-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

if rash or irritation develops an last

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 ■ Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area.
Rinse thoroughly and pat dry. ■ 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 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 using this product and ask a doctor.

Inactive Ingredients

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

Other Information

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

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