MDACNE BODY ACNE TREATMENT BENZOYL PEROXIDE- benzoyl peroxide cream

MDacne Body Acne Treatment Benzoyl Peroxide by

Drug Labeling and Warnings

MDacne Body Acne Treatment Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by MDAlgorithms Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Benzoyl Peroxide 5.0%

Purpose

Acne Treatment

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.

  Do not use 

for prolonged periods without consulting a doctor.

Keep out of reach of children.

If swallowed, contact physician or Poison Control Center immediately.

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.

Other information:

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

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.

Questions:

Contact us at support@mdacne.com

Package Labelling:

INGREDIENTS AND APPEARANCE

MDACNE BODY ACNE TREATMENT BENZOYL PEROXIDE 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71804-532
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CUCUMBER (UNII: YY7C30VXJT)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71804-532-00	90 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/28/2024

Labeler - MDAlgorithms Inc (080479826)