a49678b0-3626-f569-e053-2995a90aec81

SPL v1

SPL

SPL Set ID a49678b0-3626-f569-e053-2995a90aec81

Route

topical

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (0.5 mL)

Inactive Ingredients

polyacrylic acid (800000 mw) propylene glycol trolamine water glycerin

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-28

Description

Ethyl Alcohol 75% v/v.

Medication Information

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.

Other Information

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

Inactive Ingredients

Water (Aqua) , Glycerin, Carbomer, Phenoxyethanol, Aminomethyl propanol

Description

Ethyl Alcohol 75% v/v.

Use

Place product in a dispenser if desired

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 55105-1

Purpose: Antimicrobial

Do Not Use

on Children less than 2 months of age
on open skin wounds

Active Ingredient(s)

Ethyl Alcohol 75% v/v.

Package Label Principal Display Panel

500 ml NDC: 75778-003-50

5 L NDC: 75778-003-55

Structured Label Content

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.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Water (Aqua) , Glycerin, Carbomer, Phenoxyethanol, Aminomethyl propanol

Use

Place product in a dispenser if desired

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 55105-1 (55105-1)

Purpose: Antimicrobial

Do Not Use (Do not use)

on Children less than 2 months of age
on open skin wounds

Active Ingredient(s)

Ethyl Alcohol 75% v/v.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

500 ml NDC: 75778-003-50

5 L NDC: 75778-003-55

Advanced Ingredient Data

[{"name": "POLYACRYLIC ACID (800000 MW)", "unii": "D0I6NSZ87U", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "20.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Place product in a dispenser if desired Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "55105-1": "Purpose: Antimicrobial", "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": "on Children less than 2 months of age on open skin wounds", "Other information": "Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)", "Active Ingredient(s)": "Ethyl Alcohol 75% v/v.", "Inactive ingredients": "Water (Aqua) , Glycerin, Carbomer, Phenoxyethanol, Aminomethyl propanol", "Package Label - Principal Display Panel": "500 ml NDC: 75778-003-50 5 L NDC: 75778-003-55"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:25.508864 · Updated: 2026-03-14T22:56:34.499802