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SPL v1

SPL

SPL Set ID d477c051-dd0a-4b31-b896-b70b2a94705d

Route

TOPICAL

Published

Effective Date 2020-04-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Water Carbomer Homopolymer, Unspecified Type Isopropyl Alcohol Aminomethylpropanol Panthenol Triisopropanolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-22

Description

Ethyl Alcohol 70%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Use

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

Warnings

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

Directions

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.

Do Not Use

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

Active Ingredient

Ethyl Alcohol 70%

Other Information

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

Inactive Ingredients

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

Questions Or Comments

SAC - MIOTECH SPORTS MEDICINE

Call Toll Free: 888-947-6331

www.miotechstore.com

Principal Display Panel

NDC: 75533-070-04

MIO-GUARD^TM

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

NDC: 75533-070-16

MIO-GUARD^TM

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

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.

Structured Label Content

Use

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

Purpose

Antiseptic

Warnings

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

Directions

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.

Do Not Use (Do not use)

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

Active Ingredient

Ethyl Alcohol 70%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments (Questions or Comments)

SAC - MIOTECH SPORTS MEDICINE

Call Toll Free: 888-947-6331

www.miotechstore.com

Principal Display Panel

NDC: 75533-070-04

MIO-GUARD^TM

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

NDC: 75533-070-16

MIO-GUARD^TM

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

When Using This Product (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 (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.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIISOPROPANOLAMINE", "unii": "W9EN9DLM98", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand rub to help reduce bacteria that potentially can cause disease when water is not available.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame", "Directions": "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.", "Do not use": "in children less than 2 months of age on open skin wounds", "Active Ingredient": "Ethyl Alcohol 70%", "Other information": "Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)", "Inactive ingredients": "Aqua, Carbomer, Isopropyl Alcohol, Aminomethyl Propanol, Panthenol, Triisopropanolamine", "Questions or Comments": "SAC - MIOTECH SPORTS MEDICINE Call Toll Free: 888-947-6331 www.miotechstore.com", "Principal Display Panel": "NDC: 75533-070-04 MIO-GUARD TM 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 NDC: 75533-070-16 MIO-GUARD TM 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", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:18.088108 · Updated: 2026-03-14T22:56:21.287889