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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS:

Active Ingredient:

Benzoyl Peroxide 5.0%

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

If pregnant or breast feeding, 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 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.

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? 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

71804-250 .5OZ

res

MDACNE CUSTOMIZED CREAM (BENZOYL PEROXIDE) 
benzoyl peroxide 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71804-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71804-250-0715 mL in 1 TUBE; Type 0: Not a Combination Product10/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/07/2020
Labeler - MDalgorithms Inc. (080479826)
Registrant - MDalgorithms Inc. (080479826)

Revised: 2/2022
Document Id: d5846fe1-a82e-437e-babe-429f6a9abc64
Set id: 9727b5eb-79f4-4275-96ac-3b81f4cc973e
Version: 2
Effective Time: 20220209
 
MDalgorithms Inc.