Label: GEL HAND SANITIZER- 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 April 22, 2020

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  • Active Ingredients

    Ethyl alcohol 62%

  • Purpose

    Antimicrobial

  • Warnings

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

  • WHEN USING

    Do not use in eyes. In case of contact with eyes, rinse with water.

  • ASK DOCTOR

    Stop and ask a doctor if irritation and redness develop and persist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help promptly.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • DOSAGE & ADMINISTRATION

  • Other Information

    Store under 105ºF

  • Inactive Ingredients

    Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water

  • PRINCIPAL DISPLAY PANEL

    Drug Facts

    Repackaged & Relabeled by

    Dashpost Ltd

    Brecksville, Ohio, 44141

    www.dashpost.trade

    Manufactured in U.S.A.

  • INGREDIENTS AND APPEARANCE
    GEL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75769-143(NDC:66902-143)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75769-143-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    2NDC:75769-143-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    3NDC:75769-143-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    4NDC:75769-143-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    5NDC:75769-143-1544 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    6NDC:75769-143-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    7NDC:75769-143-2574 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    8NDC:75769-143-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Dashpost Ltd (108685594)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dashpost Ltd108685594repack(75769-143) , relabel(75769-143)
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