Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 70146-012-01, 70146-012-02, 70146-012-03, 70146-012-04
  • Packager: Dr.Sankunnis Ayurvedic Research Foundation Pvt Ltd
  • Category: HUMAN OTC DRUG LABEL

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 8, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v.

  • Purpose

    Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria that potentially could cause disease. Recommended for repeated use

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • WHEN USING

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

  • STOP USE

    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

    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 your hands. Rub hands briskly until dry.
    • No rinsing required
    • No towels needed
  • Other information

    • Do not store above 110F (43C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Vitamin E, Demineralized Water, Glycerin

  • Package Label - Principal Display Panel

    labellabel 1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70146-012
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70146-012-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:70146-012-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:70146-012-03500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    4NDC:70146-012-045000 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Dr.Sankunnis Ayurvedic Research Foundation Pvt Ltd (650517704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.Sankunnis Ayurvedic Research Foundation Pvt Ltd650517704manufacture(70146-012)
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