Mdacne Customized Cream (sulfur)
FDA Label NDC 71804-400

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 (sulfur) (NDC 71804-400). 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

→ Drug Facts:

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Otc - Pregnancy Or Breast Feeding

→ Dosage & Administration

→ Inactive Ingredient

→ Otc - Questions

→ Package Label

Drug Facts:

Active Ingredient:

Sulfur 3.0%

Otc - 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
Do not useon broken skin or large areas of
the skin. 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 acne medication at one time. ■ apply
only to areas with acne.

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.

Inactive Ingredient

Other Ingredients: Aqua (Deionized Water),
Azelaic Acid, C12-15 Alkyl Benzoate, Camellia
Sinensis (Green Tea) Extract, Caprylyl Glycol,
Cetearyl Alcohol, Chamomilla Recutita
(Chamomile) Extract, Cucumis Sativus
(Cucumber) Extract, Dimethicone, Glycerin,
Glycyrrhiza Glabra (Licorice) Extract,
Hamamelis Virginiana (Witch Hazel), Hexylene
Glycol, Hydroxyethyl Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer,
Magnesium Aluminum Silicate, Niacinamide,
Olea Europaea (Olive) Oil, Parfum
(Fragrance), PEG-150 Distearate,
Phenoxyethanol, Polysorbate-80, Potassium
Sorbate, Steareth-2, Steareth-20, Tetrasodium
EDTA, Thymus Vulgaris (Thyme) Extract,
Tocopherol (Vitamin E), Zemea (Corn)
Propanediol.