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

Purpose

Acne treatment

Description

Benzoyl peroxide 10%


Medication Information

Warnings

For external use only

Purpose

Acne treatment

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.
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

Description

Benzoyl peroxide 10%

Use

for the treatment of acne

Do Not Use

if you

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

Benzoyl peroxide 10%

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

Warnings

For external use only

Purpose

Acne treatment

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.
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

Use

for the treatment of acne

Do Not Use (Do not use)

if you

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

Benzoyl peroxide 10%

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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