SPL v2
SPL
SPL Set ID f76eb53e-643d-52cf-e053-6394a90a6e8f
Route
TOPICAL
Published
Effective Date 2023-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Alpha-tocopherol Acetate Carbomer 940 Potassium Hydroxide Niacinamide Hamamelis Virginiana Top Water Glycerin Isostearyl Alcohol Pentylene Glycol Epilobium Angustifolium Flowering Top Silicon Dioxide Fu Ling Water Phragmites Australis Stem Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-21

Description

Benzoyl Peroxide 5%


Medication Information

Warnings and Precautions

For external use only. Do not use if you have very sensitive skin or 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 treatment at a time, avoid unnecessary sun exposure and use 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 consult with a doctor if irritation becomes severe.

Indications and Usage

For the treatment of acne.

Dosage and Administration

Clean 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.

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 above.

Description

Benzoyl Peroxide 5%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water, Isostearyl Alcohol, Glycerin, Pentylene Glycol, Silica, Hamamelis Virginiana (Witch Hazel) Water, Epilobium Angustifolium Flower/Leaf/Stem Extract, Phragmites Communis Extract, Poria Cocos Extract, Niacinamide, Tocopheryl Acetate, Carbomer, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA.

Section 55105-1

Acne Treatment

Section 55106-9

Benzoyl Peroxide 5%

Package Label


Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne.

Dosage and Administration (34068-7)

Clean 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.

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 above.

Warnings and Precautions (34071-1)

For external use only. Do not use if you have very sensitive skin or 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 treatment at a time, avoid unnecessary sun exposure and use 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 consult with a doctor if irritation becomes severe.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water, Isostearyl Alcohol, Glycerin, Pentylene Glycol, Silica, Hamamelis Virginiana (Witch Hazel) Water, Epilobium Angustifolium Flower/Leaf/Stem Extract, Phragmites Communis Extract, Poria Cocos Extract, Niacinamide, Tocopheryl Acetate, Carbomer, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA.

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Benzoyl Peroxide 5%

Package Label


Advanced Ingredient Data


Raw Label Data

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