Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 28886273-a71a-46ea-e063-6394a90ac11d
Route
TOPICAL
Published
Effective Date 2024-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Water Citric Acid Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Peg/ppg-4/12 Dimethicone Propanediol Sodium Hydroxide Portulaca Oleracea Leaf Rhodomyrtus Tomentosa Fruit Edetate Disodium Glycerin Carbomer Hydrated Silica Phenoxyethanol Fragrance 13576 Sodium Citrate Xanthan Gum Butylene Glycol Chlorphenesin Dimethyl Isosorbide Lauryl Methacrylate/glycol Dimethacrylate Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-15

Description

Benzoyl peroxide 10%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 10%

Uses
  • for the treatment of acne
  • clears acne pimples and allows skin to heal
  • penetrates pores to control blackheads and whiteheads
  • helps prevent new acne blemishes from forming
Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer 1 to 3 times daily
  • once dry, follow with a non-comedogenic moisturizer if needed
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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.

Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Active Ingredient

Benzoyl peroxide 10%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information
  • avoid storing at temperatures above 100 OF (38 OC)
Inactive Ingredients

water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, fragrance, hydrated silica, hydrolyzed soy protein, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, xanthan gum

Principal Display Panel

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
If Pregnant Or Breast Feeding,

ask a health professional before use.

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
  • clears acne pimples and allows skin to heal
  • penetrates pores to control blackheads and whiteheads
  • helps prevent new acne blemishes from forming
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 1 to 3 times daily
  • once dry, follow with a non-comedogenic moisturizer if needed
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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.

Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Active Ingredient

Benzoyl peroxide 10%

Do Not Use If You (Do not use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information (Other information)
  • avoid storing at temperatures above 100 OF (38 OC)
Inactive Ingredients (Inactive ingredients)

water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, fragrance, hydrated silica, hydrolyzed soy protein, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, xanthan gum

Principal Display Panel

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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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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