Biba Acne

Biba Acne
SPL v2
SPL
SPL Set ID 448eeb45-e6a2-43da-bd04-9844aa0b5dff
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (89.162 g)
Inactive Ingredients
Water Glycerin Cetostearyl Alcohol Cetearyl Glucoside Pentylene Glycol Carbomer Homopolymer, Unspecified Type Propanediol Xanthan Gum Caprylyl Glycol Chlorphenesin Citric Acid Monohydrate Trisodium Ethylenediamine Disuccinate Sodium Hydroxide Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-07-15 Until 2026-07-15

Description

DRUG FACTS:

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

DRUG FACTS:

Uses

For the treatment of acne

Section 42229-5

DRUG FACTS:

Section 50568-5

Ask a doctor or pharmacist before use if you havesevere acne

Warnings

For external use only

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
Do Not Use
  • On sensitive skin
  • If you are allergic to benzoyl peroxide
Questions?

01+ 310-770-5831

[email protected]

Active Ingredient

Benzoyl Peroxide 2.5%

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.

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

Principal Display Panel 30 Ml Bottle Carton

BIBA

DE SOUSA

LOS ANGELES

THE

ACNE GEL

Net wt. 1.02 fl. oz. / 30 mL


Structured Label Content

Uses

For the treatment of acne

Section 42229-5 (42229-5)

DRUG FACTS:

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you havesevere acne

Purpose

Acne treatment

Warnings

For external use only

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
Do Not Use (Do not use)
  • On sensitive skin
  • If you are allergic to benzoyl peroxide
Questions?

01+ 310-770-5831

[email protected]

Active Ingredient

Benzoyl Peroxide 2.5%

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.

When Using This Product (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 (Stop use and ask a doctor if)

Irritation becomes severe.

Keep Out of Reach of Children (Keep out of reach of children)

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

Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

BIBA

DE SOUSA

LOS ANGELES

THE

ACNE GEL

Net wt. 1.02 fl. oz. / 30 mL


Advanced Ingredient Data


Raw Label Data

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