antiseptic hand sanitizer foam

SPL v1

SPL

SPL Set ID ec68ac94-2831-4cff-9627-cb40c54da4d9

Route

topical

Published

Effective Date 2020-03-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (0.62 mL)

Inactive Ingredients

water glycerin peg-10 dimethicone (600 cst)

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°C (59-86°F)
avoid freezing and excessive heat above 40°C (104°F)
do not reuse container. Dispose of properly

Inactive Ingredients

Water, Glycerol, PEG-10 Dimethicone

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

Antiseptic

HAND SANITIZER

Foam

H Higley

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

WWW.HIGLEYINC.COM

Packaging

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Keep Out of Reach of Children.

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

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 (Other information)

store between 15-30°C (59-86°F)
avoid freezing and excessive heat above 40°C (104°F)
do not reuse container. Dispose of properly

Inactive Ingredients (Inactive ingredients)

Water, Glycerol, PEG-10 Dimethicone

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

Antiseptic

HAND SANITIZER

Foam

H Higley

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

WWW.HIGLEYINC.COM

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Ethyl Alcohol 62%

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": "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": "PEG-10 DIMETHICONE (600 CST)", "unii": "8PR7V1SVM0", "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 Antiseptic HAND SANITIZER Foam H Higley Manufactured by: Higley Industries, Inc. 585 Huff St., Dubuque IA, 52003 WWW.HIGLEYINC.COM", "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°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F) do not reuse container. Dispose of properly", "Inactive ingredients": "Water, Glycerol, PEG-10 Dimethicone", "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: 2026-02-15T11:57:05.996990 · Updated: 2026-03-14T22:56:02.443544