Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f2a2dacb-9fac-41ae-984e-6278b8dc698e
Route
TOPICAL
Published
Effective Date 2017-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (0.1 mg)
Inactive Ingredients
Water Glyceryl Stearate Se Cetostearyl Alcohol Cetyl Alcohol Propylene Glycol Cocamidopropyl Betaine Glycerin Lactic Acid Benzyl Alcohol Mineral Oil Sodium Laureth Sulfate Peg-100 Stearate Glyceryl Monostearate Polyoxyl 20 Cetostearyl Ether Polysorbate 60 Carbomer 934 Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-07-13

Description

Benzoyl Peroxide 10%

Purpose

Acne medication


Medication Information

Purpose

Acne medication

Description

Benzoyl Peroxide 10%

Uses

for the treatment and prevention of acne pimples

Warnings

For external use only.

Directions
  • cleanse the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer and rinse thoroughly 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
Label Copy

Do Not Use If
  • you have very sensitive skin
  • are sensitive to benzoyl peroxide
Active Ingredient

Benzoyl Peroxide 10%

Other Information
  • keep tightly closed
  • store at controlled room temperature 20°C-25°C (68°F-77°F)
Inactive Ingredients

Water (Aqua), Glyceryl Stearate SE, Cetearyl Alcohol, Cetyl Alcohol, Propylene Glycol, Cocamidopropyl Betaine, Glycerin, Lactic Acid, Benzyl Alcohol, Mineral Oil, Sodium Laureth Sulfate, PEG-100 Stearate, Glyceryl Stearate, Ceteareth-20, Polysorbate 60, Carbomer, Titanium Dioxide (CI 77891).

Questions Or Comments?

1-888-287-1915

When Using This Product
  • avoid unnecessary sun exposure and use a sunscreen
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by 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
  • 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
  • skin irritation or redness becomes severe.
Keep Out of Reach of Children.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

for the treatment and prevention of acne pimples

Purpose

Acne medication

Warnings

For external use only.

Directions
  • cleanse the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer and rinse thoroughly 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
Label Copy

Do Not Use If (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)
  • keep tightly closed
  • store at controlled room temperature 20°C-25°C (68°F-77°F)
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glyceryl Stearate SE, Cetearyl Alcohol, Cetyl Alcohol, Propylene Glycol, Cocamidopropyl Betaine, Glycerin, Lactic Acid, Benzyl Alcohol, Mineral Oil, Sodium Laureth Sulfate, PEG-100 Stearate, Glyceryl Stearate, Ceteareth-20, Polysorbate 60, Carbomer, Titanium Dioxide (CI 77891).

Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (When using this product)
  • avoid unnecessary sun exposure and use a sunscreen
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by 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
  • 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)
  • skin irritation or redness becomes severe.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data


Raw Label Data

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