FDA.reportPublic FDA data

Mio Guard Hand Sanitizer

Manufacturer
MIO-GUARD LLC
Effective date
2020-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:33

Label at a glance#

ProductMio Guard Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand rub to help reduce bacteria that potentially can cause disease when water is not available.

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

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Carbomer, Isopropyl Alcohol, Aminomethyl Propanol, Panthenol, Triisopropanolamine

Questions or Comments

OTC - QUESTIONS SECTION

SAC - MIOTECH SPORTS MEDICINE

Call Toll Free: 888-947-6331

www.miotechstore.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 75533-070-04

MIO-GUARDTM​

Hand Sanitizer Gel

GUARD YOUR GAME

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Gel 70% (alcohol)

Net Wt. 120g e 4.2 oz

LabelLabel

NDC: 75533-070-16

MIO-GUARDTM

Hand Sanitizer Gel

GUARD YOUR GAME

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Gel 70% (alcohol)

Net Wt. 480g e 16.9 oz

Label 1Label 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75533-070-042022-01-28C16284748780-1d6a99b39-a41b-a426-e053-dadaa90af4c2d477c051-dd0a-4b31-b896-b70b2a94705d
75533-070-162022-01-28C16284748780-1d6a99b39-a41b-a426-e053-dadaa90af4c2d477c051-dd0a-4b31-b896-b70b2a94705d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75533-070-04Mio Guard Hand Sanitizer120 mL in 1 BOTTLEGEL1201
75533-070-16Mio Guard Hand Sanitizer480 mL in 1 BOTTLEGEL4801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75533-070MIO GUARD HAND SANITIZER (ALCOHOL) GEL [MIO-GUARD LLC]1Legacy NDC, 2 package rows20200423_d477c051-dd0a-4b31-b896-b70b2a94705d.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75533-07075533-070-04, 75533-070-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ISOPROPYL ALCOHOLND2M416302IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PANTHENOLWV9CM0O67ZIACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT

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
9b934390-1455-420d-8d98-b70fde784944d477c051-dd0a-4b31-b896-b70b2a94705d2020-04-22WarningsExact identifier
spl id: 9b934390-1455-420d-8d98-b70fde784944
spl set id: d477c051-dd0a-4b31-b896-b70b2a94705d

Reported adverse events (FAERS/openFDA)#

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