Label: ALOE VERA HAND SANITIZER 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 April 29, 2020

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  • DOSAGE & ADMINISTRATION

    1.Store below 15 30C (59 86F).
    2.Avoid feezing and exessve heat above 40C (104F).

  • INACTIVE INGREDIENT

    WATER

    GLYCERIN

    CARBOMER

    TRIETHANOLAMINE

    FRAGRANCE

    1) FD&C RED NO.4 (CI14700)
    2) FD&C YELLOW NO.5 (CI19140)
    3) FD&C BLUE NO.1 (CI42090)
    4) D&C RED NO.33 (CI17200)

  • INDICATIONS & USAGE

    1.Place enough poducton bonds to cover a sufare. Rub honds together unil dry.
    2.Supervise Cildren under 6 years of age when using this produdt to avoid.

  • ACTIVE INGREDIENT

    ALCOHOL

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame Do not use in cildren less than2 months of age .on open skin woundsWhen using this product keep out of eye,ears, and mouth. In case of contat with eyes, rinse thoroughly with water.
    Stop use and ask a doctor if itationo or rash ocus. These moy be signs of a senious condition.Keep gut of reach of children. If sollowed, get medical help or contorl Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALOE VERA HAND SANITIZER 
    aloe vera hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41038-002
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL307.45 mL  in 473 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41038-002-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/29/2020
    Labeler - Leadpro Inc. (041038367)
    Establishment
    NameAddressID/FEIBusiness Operations
    Leadpro Inc.041038367manufacture(41038-002)
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