Benzoyl Peroxide 10% Drug Facts

Benzoyl Peroxide 10% Drug Facts
SPL v5
SPL
SPL Set ID 9702add4-ea36-4c6b-9402-87b44f989a80
Route
TOPICAL
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Dimethicone, Unspecified Disodium Lauryl Sulfosuccinate Edetate Disodium Glycerin Methylparaben Poloxamer 182 Water Silicon Dioxide Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-06

Description

Benzoyl peroxide 10%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 10%

Use

for the treatment of acne

Warnings

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 10%

Other Information
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxide

Questions Or Comments?

1-866-634-9120

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.

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

Package/label Principal Display Panel

NDC 45802-308-96

Benzoyl Peroxide 10%

Aqueous Base, Acne Treatment Gel

NET WT 2.1 OZ (60 g)


Structured Label Content

Use

for the treatment of acne

Purpose

Acne treatment

Warnings

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 (Do not use)

if you

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

Benzoyl peroxide 10%

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxide

Questions Or Comments? (Questions or comments?)

1-866-634-9120

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.)

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 45802-308-96

Benzoyl Peroxide 10%

Aqueous Base, Acne Treatment Gel

NET WT 2.1 OZ (60 g)


Advanced Ingredient Data


Raw Label Data

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