Label: THE MITT- alcohol wipes 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 August 22, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer wipes to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Remove Mitt from the package and gently open bottom and insert hand. After the bottom has become thoroughly soiled, simply rotate hand inside Mitt and use the backside to continue removing soil and bacteria.

  • Other information

    • Store between 15-30C (59-86F)
  • Inactive ingredients

    Aloe Barbadensis Leaf, Eucalyptus oil, Alkyl polyglucoside, Disodium EDTA, Propylene glycol, Glycerin, Phenoxyethanol, Aqua

  • Package Label - Principal Display Panel

    12 pcs NDC: 80122-111-11

  • INGREDIENTS AND APPEARANCE
    THE MITT 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80122-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80122-111-1112 in 1 PACKAGE08/22/2020
    112 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/22/2020
    Labeler - Flight Armour LLC (117613888)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Riway Daily Commodity Co., Ltd540997562manufacture(80122-111)
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