Label: HAND SANITIZER gel

  • 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 2, 2020

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  • Active Ingredient(s)

    Alcohol62%

  • Purpose

    Antiseptic

  • Use

    For Hand Sanitizing

  • Warnings

    For external use only-hands.
    Flammable. Keep away from heat and flame.

  • Do not use

    /

  • WHEN USING

    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

    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 contact 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 above105°F.
    May discolor some fabrics.
    Harmful to wood finishes and plastics.

  • Inactive ingredients

    Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

  • Package Label - Principal Display Panel

    30536030 2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75209-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER 934 (UNII: Z135WT9208)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75209-009-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:75209-009-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:75209-009-0353 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:75209-009-0130 mL in 1 BOTTLE; 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 - GUANGDONG MINGLIU TECHNOLOGY DAIL-USE CHEMICAL CO., LTD. (546631081)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGDONG MINGLIU TECHNOLOGY DAIL-USE CHEMICAL CO., LTD.546631081manufacture(75209-009)
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