Label: ALTITUDE MEDICAL HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 69345-200-01, 69345-200-02, 69345-200-03
  • Packager: Altitude Medical
  • 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 October 18, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl alcohol, 69.8% v/v

  • Purpose

    Antimicrobial

  • Uses

    • Sanitize hands without requiring water or a rinse
  • Warnings

    Flammable

    For external use only

    When using this product

    • Do not use near heat or flame
    • Do not use in or near eyes
    • Discontinue use if irritation and redness develop
    • Do not use on deep or puncture wounds, consult your doctor

    Keep out of reach of children.

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directions

    • apply gel liberally to unsoiled hands and rub in thoroughly
    • allow to dry without wiping or rinsing
  • Other information

    • Store at room temperature
  • Inactive ingredients

    Water, glycerin, carbomer, glycereth-7 triacetate, triethanolamine, fragrance and tocopherol acetate.

  • PRINCIPAL DISPLAY PANEL

    AltitudeMedical
    Hand Sanitizer
    Kills 99.999% of germs without water!
    Net Contents 5/408mL (13.5 Fl oz)
    Emergency #
    1-888-959-0211

    LabelAM.jpg

  • PRINCIPAL DISPLAY PANEL

    AltitudeMedical™
    Hand Sanitizer
    Kills 99.999% of germs without water!
    Net Contents 4/500mL (16.9 Fl oz)
    Emergency # : 1-888-959-0211

    AMLabelLeft.jpg

    AMLabelRight.jpg

  • PRINCIPAL DISPLAY PANEL

    AltitudeMedical™
    Hand Sanitizer
    Kills 99.999% of germs without water!
    Net Contents 4/465mL (15.7 Fl oz)
    Emergency # : 1-888-959-0211

    465mL LEFT.jpg

    465mL RIGHT.jpg

  • INGREDIENTS AND APPEARANCE
    ALTITUDE MEDICAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69345-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69.8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERETH-7 TRIACETATE (UNII: S9W6Z48HUP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69345-200-015 in 1 BOX12/07/2016
    1408 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69345-200-024 in 1 BOX08/30/2018
    2500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69345-200-034 in 1 BOX10/30/2018
    34 in 1 BOX
    3465 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/07/2016
    Labeler - Altitude Medical (963401380)
    Registrant - CYAN Labs S.A. de C.V. (812754130)
    Establishment
    NameAddressID/FEIBusiness Operations
    CYAN Labs S.A. de C.V.812754130manufacture(69345-200) , label(69345-200) , pack(69345-200)
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