Label: GRAPE FRUIT HAND SANITIZER- ethyl 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 July 15, 2020

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  • DRUG FACTS

  • Active ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Uses

    For Hand Sanitizing

  • Warnings

    Warnings: For external use only-hands.
    Flammable: Keep away from heat and flame.
    When using this product Keep out of eyes. In case of
    contact with eyes, flush thoroughly with water.●Avoid contact with
    broken skin.●Do not inhale or ingest.
    Stop use and ask a doctor
    if skin irritation develops.

    Keep out of reach of children.

    Keep out of reach of children

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

  • Directions

    Wet hands thoroughly with product and allow to
    dry without wiping●For children under 6 use only under adult
    Supervision.●Not recommended for infants.

  • Other information

    Do not store above 105°F
    May discolor some fabrics

    Hamful to wood finishes and plastics.

  • Inactive ingredients

    Aloe Vera Leaf Juice,Grapefruit Oil, Glycerin,Triethanolamine,Carbomer,Water.

  • Package Labeling

    11

  • INGREDIENTS AND APPEARANCE
    GRAPE FRUIT HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77753-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77753-005-0112 in 1 BOX07/15/2020
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:77753-005-0212 in 1 BOX07/15/2020
    253 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:77753-005-0312 in 1 BOX07/15/2020
    360 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:77753-005-042 in 1 BOX07/15/2020
    4250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:77753-005-0512 in 1 BAG07/15/2020
    5300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:77753-005-068 in 1 BOX07/15/2020
    6350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:77753-005-078 in 1 BOX07/15/2020
    7400 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:77753-005-088 in 1 BOX07/15/2020
    8500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:77753-005-094 in 1 BOX07/15/2020
    9750 mL in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:77753-005-104 in 1 BOX07/15/2020
    101000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/15/2020
    Labeler - SHANDISHI Biological Technology Co., Ltd. (411868994)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANDISHI Biological Technology Co., Ltd.411868994manufacture(77753-005)
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