Md-acne Body Acne Treatment Cream

Md-acne Body Acne Treatment Cream
SPL v3
SPL
SPL Set ID 97981e9b-d56a-42f6-a75f-647b4732021e
Route
TOPICAL
Published
Effective Date 2018-03-29
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 Glycerin Glycyrrhiza Glabra Hexylene Glycol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Magnesium Aluminum Silicate Tea Tree Oil Peg-100 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 2018-06-01

Description

Benzoyl Peroxide 5.00%


Medication Information

Description

Benzoyl Peroxide 5.00%

Section 42229-5

Store at room temperature

Section 55105-1

Acne Treatment

Use For:

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 the same time or immerdiately 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.
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.
Do Not Use 
  • for prolonged periods without consulting a doctor.
Package Labeling:

Active Ingredient:

Benzoyl Peroxide 5.00%

Other 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, Parfum (Fragrance), PEG 100 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

Section 42229-5 (42229-5)

Store at room temperature

Section 55105-1 (55105-1)

Acne Treatment

Use For:

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 the same time or immerdiately 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.
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.
Do Not Use  (Do not use )
  • for prolonged periods without consulting a doctor.
Package Labeling:

Active Ingredient:

Benzoyl Peroxide 5.00%

Other 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, Parfum (Fragrance), PEG 100 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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