Mdacne Body Acne Treatment Cream Benzoyl Peroxide 5%

Mdacne Body Acne Treatment Cream Benzoyl Peroxide 5%
SPL v1
SPL
SPL Set ID 97529268-c45c-49c0-8eb0-15c90def69ea
Route
TOPICAL
Published
Effective Date 2024-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Water Ascorbic Acid Alkyl (c12-15) Benzoate Green Tea Leaf Caprylyl Glycol Cetostearyl Alcohol Cucumber Dimethicone, Unspecified Glycerin Glycyrrhiza Glabra Hexylene Glycol Magnesium Aluminum Silicate Melaleuca Alternifolia Leaf Peg-150 Stearate Phenoxyethanol Polysorbate 80 Potassium Sorbate Propylene Glycol Steareth-2 Steareth-20 Edetate Sodium .alpha.-tocopherol Acetate Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-28

Description

Benzoyl Peroxide 5.0%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5.0%

Use:

For the treatment of Acne. Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

For external use only.

  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.

    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 per day.
Questions:

Contact us at [email protected]

Drug Facts:

Directions:

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

Active Ingredient:

Benzoyl Peroxide 5.0%

Other Information:

Store in a cool, dry place below 20ºC (70ºF).

Package Labelling:

•  Do Not Use 

for prolonged periods without consulting a doctor.

Inactive Ingredients:

Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Extract, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, PEG-150 Stearate, Phenoxyethanol, Polysorbate-80, Potassium Sorbate, Propylene Glycol, Steareth-2, Steareth-20, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Keep Out of Reach of Children.

If swallowed, contact physician or Poison Control Center immediately.


Structured Label Content

Use:

For the treatment of Acne. Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Purpose

Acne Treatment

Warnings:

For external use only.

  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.

    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 per day.
Questions:

Contact us at [email protected]

Drug Facts: (DRUG FACTS:)

Directions:

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

Active Ingredient:

Benzoyl Peroxide 5.0%

Other Information: (Other information:)

Store in a cool, dry place below 20ºC (70ºF).

Package Labelling:

•  Do Not Use  (•  Do not use )

for prolonged periods without consulting a doctor.

Inactive Ingredients:

Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Extract, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, PEG-150 Stearate, Phenoxyethanol, Polysorbate-80, Potassium Sorbate, Propylene Glycol, Steareth-2, Steareth-20, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, contact physician or Poison Control Center immediately.


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