Benzoyl Peroxide Gel Bp

Benzoyl Peroxide Gel Bp
SPL v3
SPL
SPL Set ID 2c75b3b9-6321-dede-e063-6394a90a5880
Route
TOPICAL
Published
Effective Date 2025-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Methylparaben Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Rose Oil Polysorbate 80 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Benzoyl peroxide 5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 5%

Use

For the treatment of acne

Warning

To be sold by retail on the prescription of a Registered Medical Practitioner only

DO NOT ACCEPT IF TAGGER IS BROKEN. USE THE BUILT-IN PIN ON THE CAP TO PIERCE THE TAGGER

FOR EXTERNAL USE ONLY

Directions

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

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 or 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 use of both products and ask a doctor.

Do Not Use

if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Active Ingredient

Benzoyl peroxide 5%

Other Information

Storage: store in a cool dry place at 20º-25ºC (68º-77ºF). Do not freeze

Inactive Ingredients

methylparaben, polysorbate 80, sodium hydroxide, purified water, carbomer homopolymer

Questions Or Comments?

(754) 200-8994 (Mon-Fri 8 AM to 4 PM EST)

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

Avoid contact with eyes and mouth.

Keep the tube tightly closed after use.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Package/label Principal Display Panel

NDC 84289-216-20

Benzoyl Peroxide Gel BP

Net Wt. 20g

GOA/DRUGS/571


Structured Label Content

Use (USE)

For the treatment of acne

Purpose (PURPOSE)

Acne treatment

Warning (WARNING)

To be sold by retail on the prescription of a Registered Medical Practitioner only

DO NOT ACCEPT IF TAGGER IS BROKEN. USE THE BUILT-IN PIN ON THE CAP TO PIERCE THE TAGGER

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

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 or 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 use of both products and ask a doctor.

Do Not Use (Do not use)

if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Active Ingredient (ACTIVE INGREDIENT)

Benzoyl peroxide 5%

Other Information (OTHER INFORMATION)

Storage: store in a cool dry place at 20º-25ºC (68º-77ºF). Do not freeze

Inactive Ingredients (INACTIVE INGREDIENTS)

methylparaben, polysorbate 80, sodium hydroxide, purified water, carbomer homopolymer

Questions Or Comments? (QUESTIONS OR COMMENTS?)

(754) 200-8994 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product (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 (Stop use and ask a doctor if)
  • irritation becomes severe
Keep Out of Reach of Children (Keep out of reach of children)

Avoid contact with eyes and mouth.

Keep the tube tightly closed after use.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Package/label Principal Display Panel (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL)

NDC 84289-216-20

Benzoyl Peroxide Gel BP

Net Wt. 20g

GOA/DRUGS/571


Advanced Ingredient Data


Raw Label Data

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