MDACNE CUSTOMIZED ACNE TREATMENT BENZOYL PEROXIDE- benzoyl peroxide cream

MDacne Customized Acne Treatment Benzoyl Peroxide by

Drug Labeling and Warnings

MDacne Customized 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 2.5%

Purpose

Acne Treatment

Indications:

• 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.

When using this product

• skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs, use only one topical acne medication at a time. 
• avoid unnecessary sun exposure and use a sunscreen.
• 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.

Do not use if you

• have very sensitive skin.
• are sensitive to benzoyl peroxide. 

Stop using and ask a doctor 

is irritation becomes severe.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding,

ask a health professional before use.

Directions:

• clean the skin thoroughly before applying this product.
• cover the entire affected area with a thin layer one to three times 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
• if going outside, apply sun screen after using this product.If irritation or sensitivity develops, stop use of both products and ask a doctor.

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) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Magnesium Aluminum Silicate, PEG 150 Distearate, Phenoxyethanol, Polysorbate 80, Potassium Sorbate, Propylene Glycol, Steareth-2, Steareth 20, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Com) Propanediol.

Questions:

Contact us at support@mdacne.com

Package Labelling:

INGREDIENTS AND APPEARANCE

MDACNE CUSTOMIZED ACNE TREATMENT BENZOYL PEROXIDE 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71804-531
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 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)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71804-531-00	1 in 1 BOX	09/12/2024
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/12/2024

Labeler - MDAlgorithms Inc (080479826)