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 15, 2020

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  • Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 70% (v/v)

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses • to decrease bacteria on fabric, 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, natural fragrances, hydrogen peroxide

  • SPL UNCLASSIFIED SECTION

    LAVENDER MINT

    Made in the USA

    KILLS OVER 99.9% OF GERMS IN 20 SECONDS

    PREVENT TRANSFER OF GERMS TO CLOTHES, SKIN, FABRIC & HANDS

    *Derived from natural plant essences and oils. Safer Choice and ISO-9235 compliant. Free of petrochemicals, solvents, dyes, and pesticides.

    Distributed by KeriCure Inc®

    3701A Southwestern Blvd.

    Baltimore MD 21229

    KeriCureMedical.com

    ®All rights reserved

    Distributed by KeriCure Inc. for Molly's Suds, LLC

    Baltimore, MD 21229

    mollyssuds.com | 844-234-SUDS

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    KERICURE FABRIC AND HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78280-314
    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:78280-314-04115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/09/2020
    Labeler - Kericure Inc. (966638681)
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