Label: INSTANT HAND SANITIZER gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 2, 2010

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  • SPL UNCLASSIFIED SECTION

    Instant Hand SanitizerTM

    Fresh Scent Instant Hand Sanitizer with Aloe Vera

    • MEETS CDC HAND WASHING RECOMMENDATIONS A.B.H.C.

    25 Packets

    Each Packet Net.Wt.0.9gm

  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin without soap and water
    • recommended for repeated use
  • Warnings

    For external use only

    Flammable, keep away from fire or flame

    Do not use in the eyes. If this happens, rinse thoroughly with water

    Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

    Keep out of reach of children

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

  • Directions

    • wet hands & wrists thoroughly with product and allow to dry without wiping
    • children under 6 years of age should be supervised while using this product
  • Inactive ingredients

    aloe vera, carbomer, D&C green #5, DSC yellow #10, fragrance, purified water, triethanolamine

  • Principal Display Panel

    Instant Hand Sanitizer – Carton Label

    PIO

    Put it on®

    Instant Hand SanitizerTM

    Fresh Scent Instant Hand Sanitizer with Aloe Vera

    • MEETS CDC HAND WASHING RECOMMENDATIONS A.B.H.C.

    25 Packets

    Each Packet Net.Wt.0.9gm

    Instant Hand Sanitizer – Carton Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    instant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50607-1111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol.60 g  in .9 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    D&C Green no. 5 (UNII: 8J6RDU8L9X)  
    D&C Yellow no. 10 (UNII: 35SW5USQ3G)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (green) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50607-1111-125 in 1 BOX
    1.9 g in 1 POUCH
    2NDC:50607-1111-2144 in 1 BOX
    2.9 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/01/2010
    Labeler - B8 Sales, Inc. (833208635)
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