MDACNE CUSTOMIZED CREAM (BENZOYL PEROXIDE)- benzoyl peroxide 5% cream

MDacne Customized Cream (Benzoyl Peroxide) by

Drug Labeling and Warnings

MDacne Customized Cream (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

Purpose

Acne Treatment

INDICATIONS & USAGE

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

Warnings For external use only. When using this
product ■ skin irritation and dryness is more likely to
occur if you use another topical acne medication at the
same time. If irritation occurs, only use one topical
acne medication at one time. ■ avoid unnecessary sun
exposure and use a sunscreen ■ avoid contact with
eyes, lips and mouth ■ 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 use and ask a doctor if ■ irritation
becomes severe.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed,
get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask

a health professional before use.

DOSAGE & ADMINISTRATION

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 directed by a doctor. ■
if bothersome dryness or peeling occurs reduce
application to once a day or every other day ■ if going
outside, apply sunscreen after using this product. If
irritation or sensitivity develops, stop use of both
products and ask a doctor.

INACTIVE INGREDIENT

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) 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, Tocopherol
Acetate (Vitamin E), Zemea (Corn) Propanediol.

QUESTIONS

Questions? Dist. by Mdalgorithms Inc. San Francisco,

CA 94104. Manufactured in the USA. For customer

support contact us at support@mdacne.com

Package Label

MDacne

Customized

Treatment

Cream

Night

Dermatologist Tested

Benzoyl Peroxide 5.0%

0.5 Oz. | 15 mL

res

INGREDIENTS AND APPEARANCE

MDACNE CUSTOMIZED CREAM (BENZOYL PEROXIDE) 
benzoyl peroxide 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71804-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CUCUMBER (UNII: YY7C30VXJT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
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 (UNII: H4N855PNZ1)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71804-250-07	15 mL in 1 TUBE; Type 0: Not a Combination Product	10/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/07/2020

Labeler - MDalgorithms Inc. (080479826)

Registrant - MDalgorithms Inc. (080479826)