MDACNE CUSTOMIZED ACNE TREATMENT SULFUR- sulfur cream

MDacne Customized Acne Treatment Sulfur by

Drug Labeling and Warnings

MDacne Customized Acne Treatment Sulfur 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:

Sulfur 3.0%

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.

Do not use on

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 medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• apply only to areas with acne.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding,

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 as directed by a doctor 
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information:

Store in a cool, dry place below 20ºC (70ºF).

Inactive 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) Fruit Extract, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice Extract, Hamamelis Viginiana (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, Tocopheryl Acetate (Vitamin E), Zemea (Com) Propanediol.

Questions:

Contact us at support@mdacne.com

Package Labelling:

INGREDIENTS AND APPEARANCE

MDACNE CUSTOMIZED ACNE TREATMENT SULFUR 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71804-535
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AZELAIC ACID (UNII: F2VW3D43YT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WITCH HAZEL (UNII: 101I4J0U34)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
NIACINAMIDE (UNII: 25X51I8RD4)
GREEN OLIVE (UNII: 6HD2W46UEG)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
EDETATE SODIUM (UNII: MP1J8420LU)
THYME (UNII: CW657OBU4N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71804-535-00	1 in 1 BOX	09/11/2024
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/11/2024

Labeler - MDAlgorithms Inc (080479826)