MDACNE CUSTOMIZED CREAM (SULFUR)- sulfur 3% cream 
MDalgorithms Inc.

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.

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DRUG FACTS:

Active Ingredient:

Sulfur 3.0%

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 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 the reach of children. If swallowed,
get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, 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 directed by a doctor. ■ if
bothersome dryness or peeling occurs reduce
application to once a day or every other day.

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?  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

Sulfur

res

MDACNE CUSTOMIZED CREAM (SULFUR) 
sulfur 3% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71804-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71804-400-0115 mL in 1 TUBE; Type 0: Not a Combination Product10/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/07/2020
Labeler - MDalgorithms Inc. (080479826)
Registrant - MDalgorithms Inc. (080479826)

Revised: 2/2022
Document Id: 80392baf-fd94-4d70-b3f1-cc9a0e0eeeb5
Set id: b3ea8695-1127-49fd-901f-167a00a886a1
Version: 2
Effective Time: 20220209
 
MDalgorithms Inc.