Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a06ed13a-2ecf-43b9-8599-4cdc2b707b0b
Route
TOPICAL
Published
Effective Date 2016-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Water Petrolatum Cetyl Alcohol Steareth-2 Zinc Lactate Glycerin Potassium Cetyl Phosphate Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Xanthan Gum Benzyl Alcohol Edetate Disodium Laureth-4 Butylated Hydroxytoluene Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-12-14

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), Petrolatum, Cetyl Alcohol, Steareth-2, Zinc Lactate, Glycerin, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance (Parfum), Benzyl Alcohol, Disodium EDTA, Laureth-4, BHT, Menthol.

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), Petrolatum, Cetyl Alcohol, Steareth-2, Zinc Lactate, Glycerin, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance (Parfum), Benzyl Alcohol, Disodium EDTA, Laureth-4, BHT, Menthol.

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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