MDACNE CUSTOMIZED CREAM (SULFUR)- sulfur 3% cream

MDacne Customized Cream (Sulfur) by

Drug Labeling and Warnings

MDacne Customized Cream (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 & 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.

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.

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.

QUESTIONS

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

Sulfur 3.0%

0.5 Oz | 15 mL

res

INGREDIENTS AND APPEARANCE

MDACNE CUSTOMIZED CREAM (SULFUR) 
sulfur 3% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71804-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AZELAIC ACID (UNII: F2VW3D43YT)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
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)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
NIACINAMIDE (UNII: 25X51I8RD4)
OLIVE OIL (UNII: 6UYK2W1W1E)
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 (UNII: H4N855PNZ1)
CORN (UNII: 0N8672707O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71804-400-01	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)