Label: ARTNATURALS HAND SANITIZER- 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 June 29, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENTS:

    ETHYL ALCOHOL 62.5%

    PURPOSE:

    ANTISEPTIC

  • USES:

    HAND SANITIZER CAN 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 HEAT OR FLAME

    DO NOT USE:

    • IN CHILDREN LESS THAN 2 MONTHS OF AGE
    • ON OPEN SKIN WOUNDS

    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 INFO:

    • STORE BETWEEN 15-30C (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, VACCINUM MACROCARPON (CRANBERRY) FRUIT EXTRACT.

  • PACKAGE LABELING

    Label1

  • INGREDIENTS AND APPEARANCE
    ARTNATURALS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78706-018
    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)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78706-018-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/26/2020
    Labeler - VIRGIN SCENT INC. (034474058)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO.,LTD542355899manufacture(78706-018)