Label: MDACNE CUSTOMIZED CREAM (BENZOYL PEROXIDE)- benzoyl peroxide 5% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71804-250-07 - Packager: MDalgorithms Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 9, 2022
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- Official Label (Printer Friendly)
- DRUG FACTS:
- PURPOSE
- INDICATIONS & USAGE
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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
- PREGNANCY OR BREAST FEEDING
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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
- Package Label
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INGREDIENTS AND APPEARANCE
MDACNE CUSTOMIZED CREAM (BENZOYL PEROXIDE)
benzoyl peroxide 5% creamProduct 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)
