Label: MDACNE CUSTOMIZED ACNE CLEANSER HYDRATING 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 0.50%

    Purpose

    Acne Treatment

  • Use:

    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.

    • 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:

    Wet face. Gently massage product over entire face for 20-30 seconds. Rinse thoroughly and pat dry. Recommended for daily use.

  • Other information:

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

  • Inactive Ingredients:

    Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Cocamide MEA Cocamidopropyl Betaine, Disodium Oleamide MEA Sulfosuccinate, Ethylhexylglycerin, Glycerin, Glycol Stearate, Glycolic Acid (AHA), Glycyrrhiza Glabra (Licorice) Root Extract, Hamamelis Virginiana (Witch hazel), Hydroxypropyltrimonium Guar, Parfum (fragrance), PEG-25 Hydrogenated Castor Oil, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E).

  • Questions:

    Contact us at support@mdacne.com

  • Package Labelling:

    Label06.jpg

  • INGREDIENTS AND APPEARANCE
    MDACNE CUSTOMIZED ACNE CLEANSER HYDRATING SALICYLIC ACID 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71804-534
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71804-534-0059 mL in 1 TUBE; Type 0: Not a Combination Product09/12/2024
    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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