Label: ARMING SANITIZER GEL- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 23, 2020

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  • Active ingredient

    Ethyl alcohol 62%

  • Purpose

    Antiseptic

  • Inactive ingredients

    water, carbomer, tocopheryl acetate, glycerin, isopropyl myristate, propylene glycol, triethanolamine, aloe extract

  • Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Directions

    Scrub hands thoroughly with sanitizing gel until dry. Do not wipe off.

  • Warnings

  • when using this product

    Keep out of eyes. In case of contact with eyes, flush thoroughly with water.

  • Stop use and ask a doctor

    if irritation or rash occurs. These may be signs of a serious condition.

  • keep out of reach of children.

    If swallowed, get medical help of contact a Poison Control Center right away.

  • Other information

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • Package Label

    100ml NDC: 78250-201-01 Label

  • INGREDIENTS AND APPEARANCE
    ARMING SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78250-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78250-201-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/24/2020
    Labeler - LCM PHAMACY (695538803)
    Registrant - LCM PHAMACY (695538803)
    Establishment
    NameAddressID/FEIBusiness Operations
    LCM PHAMACY695538803manufacture(78250-201)
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