Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID d9c11b75-14ee-46e3-9b1d-c349a102e2fd
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (40 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Cocamidopropyl Hydroxysultaine Sodium C14-16 Olefin Sulfonate Xanthan Gum Potassium Hydroxide Ceramide Np Ceramide Ap Ceramide 1 Carbomer Homopolymer, Unspecified Type Niacinamide Glycolic Acid Sodium Chloride Sodium Citrate Hyaluronate Sodium Sodium Lauroyl Lactylate Sodium Hydroxide Cholesterol Phenoxyethanol Propanediol Citric Acid Monohydrate Edetate Sodium Docusate Sodium Phytosphingosine Ethylhexylglycerin Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-01

Description

Benzoyl peroxide 4%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 4%

Use

for the treatment of acne

Section 51945-4

Warnings

For external use only

Directions

• use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse wel

• use wash on entire affected area one to two 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.

Questions Or

Toll-free number 1-888-768-2915

Active Ingredient

Benzoyl peroxide 4%

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, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium c14-16 olefin sulfonate, xanthan gum, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycolic acid, sodium chloride, sodium citrate, sodium hyaluronate, sodium lauroyl lactylate, sodium hydroxide, cholesterol, phenoxyethanol, propanediol, citric acid, tetrasodium EDTA, diethylhexyl sodium sulfosuccinate, phytosphingosine, ethylhexylglycerin, benzoic acid

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

skin 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

Use

for the treatment of acne

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions

• use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse wel

• use wash on entire affected area one to two 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.

Questions Or (Questions or)

Toll-free number 1-888-768-2915

Active Ingredient (Active ingredient)

Benzoyl peroxide 4%

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, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium c14-16 olefin sulfonate, xanthan gum, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycolic acid, sodium chloride, sodium citrate, sodium hyaluronate, sodium lauroyl lactylate, sodium hydroxide, cholesterol, phenoxyethanol, propanediol, citric acid, tetrasodium EDTA, diethylhexyl sodium sulfosuccinate, phytosphingosine, ethylhexylglycerin, benzoic acid

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)

skin 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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