Label: INOVAKER LAB HAND SANITIZER- isopropyl 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 27, 2020

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  • Drug Facts

  • Active ingredient

    Isopropyl alcohol 75% v/v

    Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • 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.

    If swalowed, get medical help or contact a Poison Control Center Right away.

  • Directions

    -Place product on hands - Rub until dry

  • Inactive ingredients

    WATER (AQUA), GLYCERIN, TRIETHANOLAMINE, CARBOMER, FRAGRANCE.

  • Package Labeling:60ml

    Bottle

  • Package Labeling:120ml

    Bottle2

  • Package Labeling:250ml

    Bottle3

  • Package Labeling:500ml

    Bottle4

  • Package Labeling:4L

    Bottle5

  • INGREDIENTS AND APPEARANCE
    INOVAKER LAB HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78106-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78106-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    2NDC:78106-002-07120 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    3NDC:78106-002-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    4NDC:78106-002-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    5NDC:78106-002-064000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/24/2020
    Labeler - UH Group LLC (025029589)
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