Label: MDACNE CUSTOMIZED ACNE TREATMENT SALICYLIC ACID- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 19, 2024

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  • DRUG FACTS:

  • Active Ingredient:

    Salicylic Acid 2.0%

    Purpose

    Acne Treatment

  • Use For:

    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.

    • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
    • Because excessive drying of the skin may occur, start with one use daily. Gradually increase to two times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once per day.

    •  Do not use 

    for prolonged periods without consulting a doctor.

    Keep out of reach of children.

    If swallowed, contact physician or poison control center immediately.

  • Directions:

    Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

  • Other information:

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

  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12 15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Magnesium Aluminum Silicate, PEG 100 Stearate, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

  • Questions:

    Contact us at support@mdacne.com

  • Package Labelling:

    Label04.jpgLabel05.jpg

  • INGREDIENTS AND APPEARANCE
    MDACNE CUSTOMIZED ACNE TREATMENT SALICYLIC ACID 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71804-533
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71804-533-001 in 1 BOX09/12/2024
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/12/2024
    Labeler - MDAlgorithms Inc (080479826)
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