antiseptic hand sanitizer gel

SPL v1

SPL

SPL Set ID 2fa47aa7-3918-4af2-a598-230c14eaab9a

Route

topical

Published

Effective Date 2020-03-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (0.62 mL)

Inactive Ingredients

water glycerin ammonium acryloyldimethyltaurate 2-carboxyethyl acrylate

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-19

Purpose

Antiseptic

Description

Ethyl alcohol 62%

Medication Information

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

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

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Uses

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Purpose

Antiseptic

Directions

wet hands thoroughly with product and allow to dry without wiping
supervise children under 6 years of age when using this product to avoid swallowing

Other Information

• store between 15-30° (59-86°F)

• super avoid freezing and excessive heat above 40°C (104°F)

• do not reuse container. Dispose of properly

Inactive Ingredients

Water, Glycerol, Ammonium acryloyldimethyltaurate, 2-carboxyethyl acrylate crosspolymer

Description

Ethyl alcohol 62%

Questions?

+1-800-535-5053

You may also report serious side effects to this phone number. Mon-Fri 9.00 AM - 5.00 PM

Section 42229-5

Since H 1923

Manufactured by: Higley Industries, Inc. 585 Huff St., Dubuque IA, 52003

WWW.HIGLEYINC.COM

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient

Ethyl alcohol 62%

Structured Label Content

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

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

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Uses

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Purpose

Antiseptic

Directions

wet hands thoroughly with product and allow to dry without wiping
supervise children under 6 years of age when using this product to avoid swallowing

Other Information

• store between 15-30° (59-86°F)

• super avoid freezing and excessive heat above 40°C (104°F)

• do not reuse container. Dispose of properly

Inactive Ingredients (Inactive ingredients)

Water, Glycerol, Ammonium acryloyldimethyltaurate, 2-carboxyethyl acrylate crosspolymer

Questions?

+1-800-535-5053

You may also report serious side effects to this phone number. Mon-Fri 9.00 AM - 5.00 PM

Section 42229-5 (42229-5)

Since H 1923

Manufactured by: Higley Industries, Inc. 585 Huff St., Dubuque IA, 52003

WWW.HIGLEYINC.COM

Section 50565-1 (50565-1)

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

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Ethyl alcohol 62%

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.62", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIUM ACRYLOYLDIMETHYLTAURATE", "unii": "KBC00G95HI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "2-CARBOXYETHYL ACRYLATE", "unii": "KM1E1216WR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available", "42229-5": "Since H 1923 Manufactured by: Higley Industries, Inc. 585 Huff St., Dubuque IA, 52003 WWW.HIGLEYINC.COM", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Antiseptic", "Warnings": "Flammable, keep away from fire/flame For external use only Do not use in children less than 2 months of age on open skin wounds When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours", "Directions": "wet hands thoroughly with product and allow to dry without wiping supervise children under 6 years of age when using this product to avoid swallowing", "Questions?": "+1-800-535-5053 You may also report serious side effects to this phone number. Mon-Fri 9.00 AM - 5.00 PM", "Active ingredient": "Ethyl alcohol 62%", "Other Information": "• store between 15-30° (59-86°F) • super avoid freezing and excessive heat above 40°C (104°F) • do not reuse container. Dispose of properly", "Inactive ingredients": "Water, Glycerol, Ammonium acryloyldimethyltaurate, 2-carboxyethyl acrylate crosspolymer"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:05.916408 · Updated: 2026-03-14T22:56:00.983918