Label: MDACNE CUSTOMIZED CREAM (SULFUR)- sulfur 3% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71804-400-01 - Packager: MDalgorithms Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 9, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS:
- PURPOSE
- INDICATIONS & USAGE
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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
- PREGNANCY OR BREAST FEEDING
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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
- Package Label
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INGREDIENTS AND APPEARANCE
MDACNE CUSTOMIZED CREAM (SULFUR)
sulfur 3% creamProduct 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)
