THE MITT- alcohol wipes cloth 
Flight Armour LLC

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.

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Flight Armour- The MITT Hand Wipes

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

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 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.

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

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

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)

Revised: 8/2020
Document Id: ad79a2e5-2a50-2b2a-e053-2995a90abf3e
Set id: ad79a2e5-2a5e-2b2a-e053-2995a90abf3e
Version: 1
Effective Time: 20200822
 
Flight Armour LLC