5 Percent Benzoyl Peroxide Cleanser

5 Percent Benzoyl Peroxide Cleanser
SPL v2
SPL
SPL Set ID e82469e2-606a-4263-9aaa-08596b59ff6b
Route
TOPICAL
Published
Effective Date 2022-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Water Glycerin Sodium Lauroyl Hydroxypropyl Sulfonate Decyl Glucoside Stearic Acid Phenoxyethanol Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Sodium Chloride Ethylhexylglycerin Sodium Hydroxide Trisodium Ethylenediamine Disuccinate Hyaluronate Sodium Tert-butyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-24

Description

Benzoyl Peroxide 5%

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Description

Benzoyl Peroxide 5%

Uses

• for the treatment of acne.

Warnings

For external use only.

Directions

Sensitivity test for a new user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs follow the directions stated below.• wet area to be cleansed • apply acne wash and gently massage area for 1-2 minutes • rinse thoroughly and pat dry • because excessive drying of the skin may occur, start with one 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 a broad spectrum sunscreen after using this product • if irritation or sensitivity develops, stop use of both products and ask a doctor.

Drug Facts

Do Not Use If

• you have very sensitive skin• are sensitive to benzoyl peroxide

Package Labeling:

Active Ingredients

Benzoyl Peroxide 5%

Inactive Ingredients

Aqua (Water), Glycerin, Sodium Laurylglucosides Hydroxypropylsulfonate, Decyl Glucoside, Stearic Acid, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6, Sodium Chloride, Ethylhexylglycerin, SodiumHydroxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate, t-Butyl Alcohol.

Questions Or Comments?

Call toll free (833) 981-2335

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.

If Pregnant Or Breastfeeding

ask a health professional before use.

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.

Purpose

Acne Medication

Warnings

For external use only.

Directions

Sensitivity test for a new user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs follow the directions stated below.• wet area to be cleansed • apply acne wash and gently massage area for 1-2 minutes • rinse thoroughly and pat dry • because excessive drying of the skin may occur, start with one 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 a broad spectrum sunscreen after using this product • if irritation or sensitivity develops, stop use of both products and ask a doctor.

Drug Facts

Do Not Use If (Do not use if)

• you have very sensitive skin• are sensitive to benzoyl peroxide

Package Labeling:

Active Ingredients (Active ingredients)

Benzoyl Peroxide 5%

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Glycerin, Sodium Laurylglucosides Hydroxypropylsulfonate, Decyl Glucoside, Stearic Acid, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6, Sodium Chloride, Ethylhexylglycerin, SodiumHydroxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate, t-Butyl Alcohol.

Questions Or Comments? (Questions or Comments?)

Call toll free (833) 981-2335

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.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

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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