Label: HAND SANITIZER 7- 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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  • Active ingredient

    Ethyl alcohol 70%

  • Purpose

    Antimicrobial

  • Use

    • To decrease bacteria on skin that could cause disease
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

    Keep out of reach of children.

  • Other information

    • Store below 105°F (40°C)
    • May discolor certain fabrics or surfaces
  • Directions

    Put enough product in you palm to cover hands and rub hands together briskly until dry.

    Children under 6 years of age should be supervised when using HAND SANITIZER 7.

  • Inactive ingredients

    Water, Gycerin, Triethyleneamine, Carbomer, Fragrance

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 7 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75695-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75695-0005-129.57 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    2NDC:75695-0005-259.14 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    3NDC:75695-0005-388.72 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    4NDC:75695-0005-4118.29 mL in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    5NDC:75695-0005-51000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/29/2020
    6NDC:75695-0005-63785.41 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/29/2020
    Labeler - Sangji Enterprise Co.,LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)
    Registrant - Sangji Enterprise Co.,LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sangji Enterprise Co.,LTD Cheongwon Oriental Medical Cosmetic Branch695625894manufacture(75695-0005)
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