Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID da87cbbf-12ca-3224-e053-2995a90a25e4
Route
TOPICAL
Published
Effective Date 2022-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Sodium Citrate Caprylyl Glycol Honey Water Aloe Vera Leaf Hexylene Glycol Phytate Sodium Camphor Oil Green Tea Leaf Arnica Montana Flower Sorbitan Monostearate Glycerin .alpha.-tocopherol Acetate Kaolin Butylene Glycol Tea Tree Oil Xanthan Gum Ethylhexylglycerin Propanediol Peg-8/smdi Copolymer Docusate Sodium Azadirachta Indica Leaf Limonene, (+)- Sodium Benzoate Rice Bran Horse Chestnut Potassium Sorbate Peg-40 Stearate Indian Frankincense Dimethicone Chamaemelum Nobile Flower Sodium Hydroxide Eucalyptus Oil Phenoxyethanol Silicon Dioxide Linalool, (+/-)- Oligopeptide-10 Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-21

Description

Active Ingredient Benzoyl Peroxide 5 %


Medication Information

Warnings and Precautions

Warning

For external use only

Indications and Usage

Use:

For the treatment of acne

Dosage and Administration

Direction

Clean the skin thoroughly before applying this product

Cover the entire affected area with a thin layer one to three time 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

Description

Active Ingredient Benzoyl Peroxide 5 %

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away

Section 50566-9

Stop use and ask a doctor if

Irritation becomes severe

Section 50567-7

When using this product

Skin irritaion 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

Aviod 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

Section 50570-1

Do not use if you

have very sensitive skin

are sensitive to benzoyl peroxide

Section 51727-6

Inactive ingredients

Water/Aqua/Eau,Aloe Barbadensis

Leaf Juice,Glycerin,Carbomer,

Sodium Citrate, Phenoxyethanol,

Tocopheryl Acetate, Kaolin,

Butylene Glycol, Sodium

Hydroxide, Caprylyl Glycol,

Melaleuca Alternifolia (Tea Tree)

Leaf Oil, Xanthan Gum, Arnica

Montana Flower Extract,

Ethylhexylglycerin,Hexylene

Glycol, Propanediol, PEG-8/SMDI

Copolymer,Eucalyptus Globulus

Leaf Oil, Diethylhexyl Sodium

Sulfosuccinate, Sodium Phytate,

Melia Azadirachta Leaf Extract,

Limonene, Cinnamimum Camphora

(Camphor) Bark Oil, Sodium

Benzoate, Camellia Sinensis Leaf

Extract, Oryza Savita (Rice) Bran

Extract, Boswellia Serrata

Extract, Honey Extract,

Dimethicone, Silica, Sorbitan

Stearate, PEG-40 Stearate,

Linalool, Aesculus Hippocastanum

(Horse Chestnut) Extract,

Anthemis Nobilis Flower Extract,

Oligopeptide-10, Crystalline

Silica, Potassium Sorbate.

Section 51945-4

Section 55105-1

Purpose:

Acne Treatment

Section 55106-9

Active Ingredient

Benzoyl Peroxide 5 %

Section 60561-8

Other information

Avoid storing at extreme temperatures (below 40°F and above 100°F)


Structured Label Content

Indications and Usage (34067-9)

Use:

For the treatment of acne

Dosage and Administration (34068-7)

Direction

Clean the skin thoroughly before applying this product

Cover the entire affected area with a thin layer one to three time 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

Warnings and Precautions (34071-1)

Warning

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

Irritation becomes severe

Section 50567-7 (50567-7)

When using this product

Skin irritaion 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

Aviod 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

Section 50570-1 (50570-1)

Do not use if you

have very sensitive skin

are sensitive to benzoyl peroxide

Section 51727-6 (51727-6)

Inactive ingredients

Water/Aqua/Eau,Aloe Barbadensis

Leaf Juice,Glycerin,Carbomer,

Sodium Citrate, Phenoxyethanol,

Tocopheryl Acetate, Kaolin,

Butylene Glycol, Sodium

Hydroxide, Caprylyl Glycol,

Melaleuca Alternifolia (Tea Tree)

Leaf Oil, Xanthan Gum, Arnica

Montana Flower Extract,

Ethylhexylglycerin,Hexylene

Glycol, Propanediol, PEG-8/SMDI

Copolymer,Eucalyptus Globulus

Leaf Oil, Diethylhexyl Sodium

Sulfosuccinate, Sodium Phytate,

Melia Azadirachta Leaf Extract,

Limonene, Cinnamimum Camphora

(Camphor) Bark Oil, Sodium

Benzoate, Camellia Sinensis Leaf

Extract, Oryza Savita (Rice) Bran

Extract, Boswellia Serrata

Extract, Honey Extract,

Dimethicone, Silica, Sorbitan

Stearate, PEG-40 Stearate,

Linalool, Aesculus Hippocastanum

(Horse Chestnut) Extract,

Anthemis Nobilis Flower Extract,

Oligopeptide-10, Crystalline

Silica, Potassium Sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient

Benzoyl Peroxide 5 %

Section 60561-8 (60561-8)

Other information

Avoid storing at extreme temperatures (below 40°F and above 100°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)