Label: SIMPLY VITAL ACNE FACE CREAM- salicylic acid cream

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

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active ingredient

    Salicylic acid 2.0%

    Purpose

    Acne Treatment

  • Uses:

    • for the treatment of acne
  • Warnings:

    For external use only.

    When using this product

    skin irritation and dryness is more likely to occr if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

    Keep out of 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 appilcation daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
    • if bothersome dryness or peeling occur, reduce application to once a day or every other day.
  • Other information:

    • protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Deionized Water, Butylene Glycol, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Dimethicone, Dodecane, Echinacea Purpurea (Coneflower) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Polysorbate-20, Pyrus Malus (Apple Cider Vinegar), Sodium Hydroxide, Sodium PCA, Cymbopogon Schoenanthus (Lemongrass) Oil, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

  • Questions?

    +1 (205) 624-9177  

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SIMPLY VITAL ACNE FACE CREAM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82460-272
    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)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DODECANE (UNII: 11A386X1QH)  
    ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82460-272-0060 mL in 1 JAR; Type 0: Not a Combination Product02/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/01/2022
    Labeler - ALPHA PLANTS INC (118246522)
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