Label: ARTNATURALS HAND SANITIZER NATURAL ELEMENTS CLEANSING FORMULA- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 1, 2020

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  • Drug Facts

  • Active ingredient[s]

    Ethyl Alcohol 62.5%

    Purpose

    Antiseptic

  • Use[s]

    Hand sanitizer cap help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not use

    • On open skin wounds
    • In children less than 2 months of age

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor 

    if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other inforamtion

    • Store between 15-30 (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water (Aqua), Glycerin, Fragrance / Parfum, Carbomer, Aminomethyl Propanol, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Actinidia Chinensis (Kiwi) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Punica Granatum (Pomegranate) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract.

  • Package Labeling:78706-003-01

    Front LabelBack Label

  • Package Labeling:78706-003-02

    Label2

  • Package Labeling:78706-003-03

    Front Label3Back Label3

  • Package Labeling:78706-003-04

    Front Label4Back Label4

  • INGREDIENTS AND APPEARANCE
    ARTNATURALS HAND SANITIZER NATURAL ELEMENTS CLEANSING FORMULA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78706-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.625 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    BLUEBERRY (UNII: 253RUG1X1A)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78706-003-01946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/2020
    2NDC:78706-003-021890 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/2020
    3NDC:78706-003-033780 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/2020
    4NDC:78706-003-04473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/03/2020
    Labeler - Virgin Scent Inc. (034474058)
    Establishment
    NameAddressID/FEIBusiness Operations
    GORDON LABORATORIES,INC008328619manufacture(78706-003)
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