Drug Facts:
Active Ingredient:
Benzoyl Peroxide 5.0%
Mdacne Customized Cream (benzoyl Peroxide)
FDA Label NDC 71804-250
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mdalgorithms Inc. for the product Mdacne Customized Cream (benzoyl Peroxide) (NDC 71804-250). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts:, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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.
Otc - 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.
Otc - Questions
Questions? Dist. by Mdalgorithms Inc. San Francisco,
CA 94104. Manufactured in the USA. For customer
support contact us at [email protected]
Package Label
MDacne
Customized
Treatment
Cream
Night
Dermatologist Tested
Benzoyl Peroxide 5.0%
0.5 Oz. | 15 mL
res
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