Label: SANI PROFESSIONAL HANDS INSTANT SANITIZING WIPES- alcohol cloth

  • NDC Code(s): 10819-6006-1, 10819-6007-1, 10819-6008-1
  • Packager: Professional Disposables International, Inc.
  • 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 October 21, 2022

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  • Active Ingredient

    Ethyl Alcohol 70% by volume

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on the skin

  • Warnings

    For external use only

    Flammable. Keep away from fire or flame

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Do not use in or contact with eyes

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

  • Keep out of reach of children

    Keep out of reach of children unless under adult supervision

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

  • Directions

    Canister:

    to dispense, lift cover, remove seal, pull center sheet from roll, twist to a point, feed through dispenser hole in cover. Keep cap closed to prevent moisture loss.

    use entire wipe to thoroughly wipe hands, fingers, and wrists

    for dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe

    discard after single use

    Packet:

    open packet

    use entire wipe to thoroughly wipe hands, fingers, and wrists

    to sanitize, use multiple wipes

    discard after single use

  • Other information

    Lot No. and Expiration Date can be found on canister

  • Inactive ingredients

    aloe barbadensis leaf juice, glycerin, propylene glycol, purified water, tocopheryl acetate

  • Principal display panel

    Packet

    packetCanister, 150ct

    front 150

    back 150

    Canister, 300ct

    front 300back 300

  • INGREDIENTS AND APPEARANCE
    SANI PROFESSIONAL HANDS INSTANT SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-6006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-6006-13.23 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2020
    SANI PROFESSIONAL HANDS INSTANT SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-6007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-6007-1484 mL in 1 CANISTER; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2020
    SANI PROFESSIONAL HANDS INSTANT SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-6008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-6008-1805.44 mL in 1 CANISTER; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2020
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-6006, 10819-6007, 10819-6008)
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