Label: KERICURE FABRIC AND HAND SANITIZER- isopropyl alcohol spray

  • 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 3, 2020

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  • Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 70% (v/v)

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses • to decrease bacteria on fabrics, clothes, hands, skin & surfaces that could cause disease • for repeated use

  • Warnings

    For external use only • Flammable, Keep away from heat or flame • Do not use on children less than 2 months of age  on open skin wounds • When using this product keep out of eyes, ears and mouth • In case of contact with eyes, rinse eyes thoroughly with water • do NOT ingest • If swallowed, seek medical help or contact a Poison Control Center right away

    • Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions • Shake bottle before use • Spray onto desired area to fully cover the area • Rub into skin where applied or rub hands together • No need to rub into the fabric or surface • Do not over saturate clothing or fabrics • Spot test fabrics prior to use • Adult supervision recommended 

  • STORAGE AND HANDLING

    Other Information • Do not store bottle above 105°F • May discolor some fabrics • harmful to some wood finishes

  • INACTIVE INGREDIENT

    Inactive Ingredients • Water, glycerin, hydrogen peroxide

  • SPL UNCLASSIFIED SECTION

    Made in the USA 

    KILLS MORE THAN 99.9% OF GERMS

    UNSCENTED

    PREVENT TRANSFER OF GERMS TO CLOTHES, FABRICS, HANDS & SURFACES

    KeriCureMedical.com

    ® KeriCure Inc • All rights reserved

    Distributed by KeriCure Inc

    3701A Southwestern Blvd. Baltimore MD 21229

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    KERICURE FABRIC AND HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78280-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78280-306-04115 mL in 1 BOTTLE, SPRAY; 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 - Kericure Inc. (966638681)
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