Biba Acne Gel
FDA Label NDC 83834-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Esthetic Underground, Inc. for the product Biba Acne (NDC 83834-001). 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 other, active ingredient, purpose, uses, warnings, do not use, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS:

DISTRIBUTED BY:
www.estheticunderground.com
Los Angeles CA 90036

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne treatment

Uses

For the treatment of acne

Warnings

For external use only

Do Not Use

  • On sensitive skin
  • If you are allergic to benzoyl peroxide

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you have severe acne

When Using This Product

Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time

  • If irritation occurs, use one topical acne medication at a time
  • Avoid contact with eyes, lips & 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
  • Avoid unnecessary sun exposure and use sunscreen.

Stop Use And Ask A Doctor If

Irritation becomes severe.

Keep Out Of Reach Of Children

If swallowed, call a poison control center or get medical help right away

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 dryness 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 of peeling occurs, reduce application to once a day every other day

Inactive Ingredients

Water (Aqua), Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Chlorphenesin, Carbomer, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Sodium Hydroxide, Citric Acid.

Principal Display Panel - 30 Ml Bottle Carton

BIBA
DE SOUSA
LOS ANGELES

THE
ACNE GEL

Net wt. 1.02 fl. oz. / 30 mL

Principal Display Panel (30 mL Bottle Carton)

Principal Display Panel (30 mL Bottle Carton)

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