Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0bdf9f38-5763-a4d0-e063-6394a90a41dc
Route
TOPICAL
Published
Effective Date 2023-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (2.5 g)
Inactive Ingredients
Glyceryl Monostearate Glycerin Dimethicone Plantago Ovata Seed Water Dihexadecyl Phosphate Phenoxyethanol Stearic Acid .alpha.-tocopherol Acetate Cetyl Alcohol Caprylyl Glycol Primula Veris Alchemilla Xanthochlora Flowering Top Xanthan Gum Veronica Officinalis Flowering Top Comfrey Root Camellia Oleifera Leaf Magnesium Aluminum Silicate Hexylene Glycol Ethylhexyl Gallate Ceteth-10 Phosphate Aloe Vera Leaf Melissa Officinalis Leaf Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Ethylhexylglycerin Achillea Millefolium Imperata Cylindrica Root Azadirachta Indica Leaf Chamomile Sulfur Linolenic Acid Dodecyl Gallate Saw Palmetto Soy Sterol Medium-chain Triglycerides Cetostearyl Alcohol Peg-100 Stearate Linoleic Acid Hyaluronate Sodium Edetate Disodium Anhydrous Malva Sylvestris Flowering Top Mentha Piperita Leaf Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-06

Description

Active ingredient Benzoyl Peroxide 2.5%


Medication Information

Warnings and Precautions

Warning : For external use only

Indications and Usage

Uses. For the treatment of acne

Dosage and Administration

Direction:

After cleansing and toning apply lotion over the entire face. Use daily. If going outside use a sunscreen

Allow Clearogen to dry then follow directions in the sunscreen labeling. If irritation or sensitivity develops, discontinue use of all products, and consult a doctor.

Description

Active ingredient Benzoyl Peroxide 2.5%

Section 50565-1

Keep out of reach of children.

Section 50566-9

If excessive irritation occurs reduce application to once a day. Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, consult a doctor.

Section 50567-7

Avoid contact with eye, If product gets into eyes, rinse thoroughly with water.

Section 50570-1

Avoid unnecessary sun exposure and use sunscreen.

Section 51727-6

Inactive Ingredient:

Aqua (Water), Linolenic Acid (Alpha & Gamma), Linoleic Acid,Glycerin, Glycine Soja (Soyabean) Sterols, Dodecyl Gallate, Octyl Ethylhexyl Gallate, Serenoa Serrulata Fruit Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol & Dicetyl Phosphate & Ceteth-10 Phosphate, Dimethicone, Aloe Barbadensis Leaf Extract, Glyceryl Stearate & PEG-100 Stearate, Sodium Hyaluronate, Cetyl Alcohol, Caprylyl Glycol, Phenoxyethanol,Extract of Malva Sylvestris (Mallow), Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Imperata Cylindrica Root Extract, Stearic Acid, Symphytum Officinale Extract, Camellia Oleifera(Green Tea)Leaf Exact, Tocopherol, Plantago Ovata Seed Extract, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Melia Azadirachta Leaf Extract, Chamomilla Recutita Flower Exact, Xanthan Gum, Ethylhexyl glycerin, Sulfur, Disodium EDTA, Magnesium Aluminum Silicate, Hexylene Glycol.

Section 51945-4

Section 55105-1

Purpose- Acne Treatment

Section 55106-9

Active ingredient

Benzoyl Peroxide 2.5%

Section 60561-8

Not applicable


Structured Label Content

Indications and Usage (34067-9)

Uses. For the treatment of acne

Dosage and Administration (34068-7)

Direction:

After cleansing and toning apply lotion over the entire face. Use daily. If going outside use a sunscreen

Allow Clearogen to dry then follow directions in the sunscreen labeling. If irritation or sensitivity develops, discontinue use of all products, and consult a doctor.

Warnings and Precautions (34071-1)

Warning : For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

If excessive irritation occurs reduce application to once a day. Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, consult a doctor.

Section 50567-7 (50567-7)

Avoid contact with eye, If product gets into eyes, rinse thoroughly with water.

Section 50570-1 (50570-1)

Avoid unnecessary sun exposure and use sunscreen.

Section 51727-6 (51727-6)

Inactive Ingredient:

Aqua (Water), Linolenic Acid (Alpha & Gamma), Linoleic Acid,Glycerin, Glycine Soja (Soyabean) Sterols, Dodecyl Gallate, Octyl Ethylhexyl Gallate, Serenoa Serrulata Fruit Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol & Dicetyl Phosphate & Ceteth-10 Phosphate, Dimethicone, Aloe Barbadensis Leaf Extract, Glyceryl Stearate & PEG-100 Stearate, Sodium Hyaluronate, Cetyl Alcohol, Caprylyl Glycol, Phenoxyethanol,Extract of Malva Sylvestris (Mallow), Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Imperata Cylindrica Root Extract, Stearic Acid, Symphytum Officinale Extract, Camellia Oleifera(Green Tea)Leaf Exact, Tocopherol, Plantago Ovata Seed Extract, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Melia Azadirachta Leaf Extract, Chamomilla Recutita Flower Exact, Xanthan Gum, Ethylhexyl glycerin, Sulfur, Disodium EDTA, Magnesium Aluminum Silicate, Hexylene Glycol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose- Acne Treatment

Section 55106-9 (55106-9)

Active ingredient

Benzoyl Peroxide 2.5%

Section 60561-8 (60561-8)

Not applicable


Advanced Ingredient Data


Raw Label Data

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