Label: IRIS HAND SANITIZING WIPES- alcohol cloth

  • 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 January 6, 2016

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  • Active Ingredient (in each wipe)

    Ethyl Alcohol .....62%

  • Purpose

    Antimicrobial

  • Indications and Usages

    • For hand sanitizing to decrease bacteria on the skin when water and soap are not available.
    • Reccomended for repeated use
  • Warnings

    For external use only

    Flammable: keep away from fire or flame

    When using this product do not use in or near eyes. If contact occurs, flush thoroughly with water.

    Stop use and contact a doctor if irritation or redness persists for more than 72 hours.

    Keep out of reach of children unless inder adult supervision. if swallowed, get medical help or contact a Poison Control Center right away.

  • Keep out of reach of children

    Keep out of reach of children unless inder adult supervision. if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • To start feed see illustrations
    • to use open cap and pull out wipe
    • Thoroughly wipe hand for approximately 30 seconds
    • throw used wipe in trash 
    • do not flush
  • Inactive Ingredients

    Aloe barbadensis leaf juice, tocopheryl acetate, water

  • Label

    Kills 99.99% of germs

    Iris Hand Sanitizing Wipes

    Moisturizes with aloe vera & vitamin E

    240 Pre-treated textured sheets

    240 wipes 5.5 in x 6.75 in (13.97 cmx 17.14 cm)

    Label

  • INGREDIENTS AND APPEARANCE
    IRIS HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61504-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF.01 g  in 100 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 37.98 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61504-140-30488 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/31/2016
    Labeler - Amerifoods Trading Company (626388680)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes International161104729manufacture(61504-140)
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