FDA.reportPublic FDA data

The Mitt

Manufacturer
Flight Armour LLC | Ningbo Riway Daily Commodity Co., Ltd
Effective date
2020-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:33

Label at a glance#

ProductThe Mitt
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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.

Storage and handling

Store between 15-30C (59-86F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12 pcs NDC: 80122-111-1112 pcs NDC: 80122-111-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN1
1489307ethanol 0.7 ML/ML Medicated PadSCD1
1489307ethanol 70 % Medicated PadSY1
1489307ethanol 70 % Medicated WipesSY1
1489307ethyl alcohol 70 % ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80122-111-112023-01-30C16284748780-1f386c64a-0a39-0266-e053-dadaa90a7c1aFlight Armour- The MITT Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80122-111-11The Mitt12 in 1 PACKAGECLOTH121
80122-111-11The Mitt12 mL in 1 NOT APPLICABLECLOTH121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80122-111THE MITT (ALCOHOL WIPES) CLOTH [FLIGHT ARMOUR LLC]1Legacy NDC, 2 package rows20200823_ad79a2e5-2a5e-2b2a-e053-2995a90abf3e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80122-11180122-111-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURYL GLUCOSIDE76LN7P7UCUIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
EUCALYPTUS OIL2R04ONI662IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ad79a2e5-2a50-2b2a-e053-2995a90abf3ead79a2e5-2a5e-2b2a-e053-2995a90abf3e2020-08-22WarningsExact identifier
spl id: ad79a2e5-2a50-2b2a-e053-2995a90abf3e
spl set id: ad79a2e5-2a5e-2b2a-e053-2995a90abf3e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.