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SPL v4

SPL

SPL Set ID 1abf5aca-346f-0d18-e063-6294a90a9339

Route

TOPICAL

Published

Effective Date 2024-06-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Aminomethylpropanol Carbomer 980 Glycerin Water

Identifiers & Packaging

Pill Appearance

Color: blue Color: green Color: pink Color: black

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Alcohol 75% ------------------------------- Antibacterial

Purpose

Anti-Bacterial Uses Effective in eliminating harmful germs and bacteria when soap and water are unavailable

Medication Information

Purpose

Anti-Bacterial

Uses

Effective in eliminating harmful germs and bacteria when soap and water are unavailable

Description

Alcohol 75% ------------------------------- Antibacterial

Users

Effective in eliminating harmful germs and bacteria when soap and water are unavailable.

Section 50565-1

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

Section 51945-4

Warnings

For external use only. Flammable.Keep away from fire or flames.

Directions

Place enough product in palm to thoroughly cover hands.Rub hands together briskly 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

When using this productdo not use in or near the eyes. In case of eye contact, flush eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness develops and lasts more than 72 hours.

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

Active Ingredient

Alcohol 75% ------------------------------- Antibacterial

Other Information

Store between 15 - 30c (59 - 86f)

Avoid freezing and excessive heat above 40c (104F)

Inactives Ingredient

Aminomethylpropanol, Carbomer, Glycerin, Purified water USP

Structured Label Content

Users

Effective in eliminating harmful germs and bacteria when soap and water are unavailable.

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 51945-4 (51945-4)

Purpose

Anti-Bacterial

Uses

Effective in eliminating harmful germs and bacteria when soap and water are unavailable

Warnings

For external use only. Flammable.Keep away from fire or flames.

Directions

Place enough product in palm to thoroughly cover hands.Rub hands together briskly 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

When using this productdo not use in or near the eyes. In case of eye contact, flush eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness develops and lasts more than 72 hours.

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

Active Ingredient (Active ingredient)

Alcohol 75% ------------------------------- Antibacterial

Other Information (Other information)

Store between 15 - 30c (59 - 86f)

Avoid freezing and excessive heat above 40c (104F)

Inactives Ingredient (Inactives ingredient)

Aminomethylpropanol, Carbomer, Glycerin, Purified water USP

Advanced Ingredient Data

[{"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 980", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Users": "Effective in eliminating harmful germs and bacteria when soap and water are unavailable.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Anti-Bacterial Uses Effective in eliminating harmful germs and bacteria when soap and water are unavailable", "Warnings": "For external use only. Flammable.Keep away from fire or flames.", "Directions": "Place enough product in palm to thoroughly cover hands.Rub hands together briskly 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 When using this product do not use in or near the eyes. In case of eye contact, flush eyes thoroughly with water. Stop use and ask a doctor if irritation and redness develops and lasts more than 72 hours. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "Active ingredient": "Alcohol 75% ------------------------------- Antibacterial", "Other information": "Store between 15 - 30c (59 - 86f) Avoid freezing and excessive heat above 40c (104F)", "Inactives ingredient": "Aminomethylpropanol, Carbomer, Glycerin, Purified water USP"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.840763 · Updated: 2026-03-14T23:11:19.831195