drug facts

drug facts

SPL v11

SPL

SPL Set ID b0fb3d45-a5c9-4d3c-a840-1b7564ecb3f8

Route

topical

Published

Effective Date 2012-02-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (64.5 mL)

Inactive Ingredients

carbomer interpolymer type a (55000 cps) edetic acid glycerin water edetol

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 1999-06-01

Purpose

Antiseptic Handwash

Description

Antiseptic Handwash

Medication Information

Warnings

Flammable, keep away from fire or flame when using this product

For External Use Only

Uses

For hand washing to decrease bacteria on the skin.
Recommended for repeated use.

Purpose

Antiseptic Handwash

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

For Spill/Exposure Emergency Response Service in English, French and Spanish (and 23 other languages), call CARECHEM24 at 866-928-0789.

Inactive Ingredients

Acrylates/C10/30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Purified Water and Tetrahydroxypropyl Ethylenediamine.

Description

Antiseptic Handwash

Questions?

Call 610-644-8335

Section 42229-5

Do not use in eyes.
In case of eye contact, flush with water for 15 minutes.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.
Avoid contact with broken skin.

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

Place holder text

Active Ingredients

Ethanol 64.5 (w/w)

Structured Label Content

Warnings

Flammable, keep away from fire or flame when using this product

For External Use Only

Uses

For hand washing to decrease bacteria on the skin.
Recommended for repeated use.

Purpose

Antiseptic Handwash

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

For Spill/Exposure Emergency Response Service in English, French and Spanish (and 23 other languages), call CARECHEM24 at 866-928-0789.

Inactive Ingredients

Acrylates/C10/30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Purified Water and Tetrahydroxypropyl Ethylenediamine.

Questions?

Call 610-644-8335

Section 42229-5 (42229-5)

Do not use in eyes.
In case of eye contact, flush with water for 15 minutes.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.
Avoid contact with broken skin.

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)

Place holder text

Active Ingredients

Ethanol 64.5 (w/w)

Advanced Ingredient Data

[{"name": "CARBOMER INTERPOLYMER TYPE A (55000 CPS)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "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": "EDETOL", "unii": "Q4R969U9FR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "64.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand washing to decrease bacteria on the skin. Recommended for repeated use.", "42229-5": "Do not use in eyes. In case of eye contact, flush with water for 15 minutes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. Avoid contact with broken skin.", "50565-1": "Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.", "51945-4": "Place holder text", "Purpose": "Antiseptic Handwash", "Warnings": "Flammable, keep away from fire or flame when using this product For External Use Only", "Directions": "Wet hands thoroughly with product and allow to dry without wiping.", "Questions?": "Call 610-644-8335", "Other Information": "For Spill/Exposure Emergency Response Service in English, French and Spanish (and 23 other languages), call CARECHEM24 at 866-928-0789.", "Active Ingredients": "Ethanol 64.5 (w/w)", "Inactive Ingredients": "Acrylates/C10/30 Alkyl Acrylate Crosspolymer, EDTA, Fragrance, Glycerin, Purified Water and Tetrahydroxypropyl Ethylenediamine."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:28.414926 · Updated: 2026-03-14T23:01:27.375563