Label: 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 June 11, 2020

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  • Active ingredient

    Ethyl Alcohol v/v 60-80%

  • Purposes

    Antimicrobial

  • Uses

    Hand sanitizer to decrease virus and bacteria on the skin that could cause disease

    Recommended for repetead use

  • Warnings

    For external use only: hands

    Flammable, keep away from fire and flame

  • When using this product

    keep out of eyes, do not use in or near the eyes

    In case of contact with eyes, flush thorougly with water

    Avoid contact with broken skin

    Do not inhale or ingest

  • When using this product

    keep out of eyes, do not use in or near the eyes

    In case of contact with eyes, flush thorougly with water

    Avoid contact with broken skin

    Do not inhale or ingest

  • Stop use and ask a doctor if

    irritation and redness develop

    condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

  • keep out of reach of children

    if swallowed, get medical help or contact a poison control center right away

  • Directions

    Put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

    For children under 6 years of age should be supervised when using this product

    not recommended for infants

  • other information

    store below 105 f 40 c

    may discolor certain fabrics

    harmful to wood finishes and plastics

  • inactive ingredients

    purified water, hydroxypropyl methylcellulose hpmc, carboxymethyl cellulose, carbomer, glycerine usp

  • questions or comments

    visit www.cleanspure.com

  • PRINCIPAL DISPLAY

    label 1000 ml ADVANCED HAND SANITIZER

    KEEP HANDS FEELING SOFT

    TRUSTED FORMULA

    MAZIMUN PROTECTION

    REFRESHING GEL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74543-193
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.6 mL  in 100 mL
    HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD) 0.1 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.2 mL  in 100 mL
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74543-193-121000 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/11/2020
    Labeler - MARGREY INDUSTRIAL SA DE CV (814572392)
    Registrant - MARGREY INDUSTRIAL SA DE CV (814572392)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARGREY INDUSTRIAL SA DE CV814572392manufacture(74543-193) , pack(74543-193) , label(74543-193)
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