Label: HAND SANITIZER WITH ALOE VERA- alcohol liquid

  • 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 31, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    ETHYL ALCOHOL 65%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizer use to reduce bacteria on skin
    • Recommended for repeated use
  • Warnings

    Flammable, keep away from fire and flames.

    For external use only

    When using this product

    • do not get into eyes

    • if contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develops

    Keep out of the reach of children

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
  • Inactive ingredients

    WATER, GLYCERIN, TETRAHYDROXYPROPYL ETHYLENEDIAMINE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,

    ALOE VERA GEL, FRAGRANCE

  • PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label

    NDC 60717-001-01

    HAND SANITIZER with ALOE VERA

    128 FL. OZ. (3785 mL)

    PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WITH ALOE VERA 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60717-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETOL (UNII: Q4R969U9FR)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60717-001-011 in 1 CARTON10/31/2014
    13785 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E10/31/2014
    Labeler - RNA PHARMA LLC (079103999)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA LLC079103999manufacture(60717-001)
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