Acne Med 10%

Acne Med 10%
SPL v5
SPL
SPL Set ID 45ad7429-ccd0-28f6-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2023-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Carbomer Homopolymer, Unspecified Type Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

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
  • 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 
  • if you are sensitive to benzoyl peroxide
Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Other Information
  • Store at room temperature. Keep away from heat or direct sunlight.
Package Labeling:

Inactive Ingredients

Purified Water, Glycerin, Propylene Glycol, Carbomer, Sodium Hydroxide.

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 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 Poison Control Center right away.


Structured Label Content

Use
  • for the treatment of acne
Purpose

Acne Treatment

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 products and ask a doctor.
Do Not Use (Do not use)
  • if you have very sensitive skin 
  • if you are sensitive to benzoyl peroxide
Drug Facts

Active Ingredient (Active ingredient)

Benzoyl Peroxide 10%

Other Information (Other information)
  • Store at room temperature. Keep away from heat or direct sunlight.
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Purified Water, Glycerin, Propylene Glycol, Carbomer, Sodium Hydroxide.

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 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 Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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