Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 8ed6ee51-816e-4c83-a437-4ceaa339b130
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (55 mg)
Inactive Ingredients
Water Isostearyl Alcohol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-07-01

Description

Benzoyl peroxide 5.5%

Purpose

Acne medication


Medication Information

Purpose

Acne medication

Description

Benzoyl peroxide 5.5%

Uses
  • for the treatment of acne
  • dries and clears acne blemishes and allows skin to heal
Section 51945-4

Warnings

For external use only

Directions
  • 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 prdoucts and ask a doctor.

Active Ingredient

Benzoyl peroxide 5.5%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information

store at 20 - 25 C (68 to 77 F)

Inactive Ingredients

water, isostearyl alcohol, glycerin, pentylene glycol, silica, carbomer, capryloyl salicylic acid, potassium hydroxide, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, epilobium angustifolium flower/leaf/stem extract

Questions Or Comments?

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. 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.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • for the treatment of acne
  • dries and clears acne blemishes and allows skin to heal
Section 51945-4 (51945-4)

Purpose

Acne medication

Warnings

For external use only

Directions
  • 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 prdoucts and ask a doctor.

Active Ingredient (Active ingredient)

Benzoyl peroxide 5.5%

Do Not Use If You (Do not use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information (Other information)

store at 20 - 25 C (68 to 77 F)

Inactive Ingredients (Inactive ingredients)

water, isostearyl alcohol, glycerin, pentylene glycol, silica, carbomer, capryloyl salicylic acid, potassium hydroxide, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, epilobium angustifolium flower/leaf/stem extract

Questions Or Comments? (Questions or comments?)

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. 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.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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