drug facts

drug facts
SPL v1
SPL
SPL Set ID 06950d35-daa8-4ea3-bd33-6e9c162e2a63
Route
topical
Published
Effective Date 2024-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzoyl peroxide (100 mg)
Inactive Ingredients
water glycerin propylene glycol cocamidopropyl hydroxysultaine sodium c14-16 olefin sulfonate potassium hydroxide ceramide np ceramide ap ceramide 1 carbomer homopolymer, unspecified type niacinamide glycolic acid sodium chloride trideceth-6 triethyl citrate sodium citrate hyaluronate sodium sodium hydroxide sodium lauroyl lactylate cholesterol propanediol edetate sodium caprylyl glycol docusate sodium phytosphingosine xanthan gum acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) benzoic acid peg-30 dipolyhydroxystearate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-12-01

Purpose

Acne treatment

Description

Benzoyl peroxide 10%


Medication Information

Warnings

For external use only

Purpose

Acne treatment

Directions

• use every morning and evening

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

• rinse well

• 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.

Other Information

store at 20° - 25°C (68° to 77°F)

Inactive Ingredients

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium c14-16 olefin sulfonate, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, , niacinamide, glycolic acid, trideceth-6, triethyl citrate, sodium citrate, sodium hyaluronate, sodium hydroxide, sodium lauroyl lactylate, cholesterol, propanediol, tetrasodium EDTA, caprylyl glycol, diethylhexyl sodium sulfosuccinate, phytosphingosine, xanthan gum, acrylates/c10-30 alkyl acrylate crosspolymer, benzoic acid, PEG-30 dipolyhydroxystearate

Description

Benzoyl peroxide 10%

Use

for the treatment of acne

Section 51945-4

Questions Or

Toll-free number 1-888-768-2915

Active Ingredient

Benzoyl peroxide 10%

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

Warnings

For external use only

Purpose

Acne treatment

Directions

• use every morning and evening

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

• rinse well

• 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.

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, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, , niacinamide, glycolic acid, trideceth-6, triethyl citrate, sodium citrate, sodium hyaluronate, sodium hydroxide, sodium lauroyl lactylate, cholesterol, propanediol, tetrasodium EDTA, caprylyl glycol, diethylhexyl sodium sulfosuccinate, phytosphingosine, xanthan gum, acrylates/c10-30 alkyl acrylate crosspolymer, benzoic acid, PEG-30 dipolyhydroxystearate

Use

for the treatment of acne

Section 51945-4 (51945-4)

Questions Or (Questions or)

Toll-free number 1-888-768-2915

Active Ingredient (Active ingredient)

Benzoyl peroxide 10%

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