Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID d06053bb-dbea-4c68-ad2c-65a157bd2fdf

Route

TOPICAL

Published

Effective Date 2011-09-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Isopropyl Alcohol Edetol Carbomer Homopolymer Type C

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-09-06

Description

Ethanol (62%)

Purpose

Hand Antiseptic

Medication Information

Purpose

Hand Antiseptic

Description

Ethanol (62%)

Uses

Hand antiseptic to decrease bacteria on the skin.

Section 51945-4

Warnings

Flammable, For external use only.

Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly with water.

Discontinue use if irritation and redness develops.

Directions

Dispense an adequate amount (approx. 5 mL), rubbing all surfaces of both hands for at least 15 seconds.
Allow to dry without wiping.

Active Ingredient

Ethanol (62%)

Inactive Ingredients

Deionized Water, Isopropanol, Hydrogenated Starch Hydrolysate, Carbomer, THP Ethylendiamine, Fragrance

Principal Display Panel

NDC 64064-002-04

Instant Hand

Sanitizer

No Rinsing

Desinfectant

Instantane Pour Les Mains

Sans Rincage

Clinishield

Manufactured in U.S.A.

Fabrique Aux E.-U.

Evonik Stockhausen, LLC

Greensboro, NC 27406

1-800-334-0242 www.CliniShield.com

Imported by

Trans Canada Distribution Inc.

Mississauga, ON L5L 5Y7

Net Contents 32.82 Fl Oz

(1000 mL)

Contenu Net 1 L

Stock No. 31795

No. De Stock 31795

Stop Use and Ask Doctor If

Skin or eye irritation persists for more than 72 hours

Keep Out of Reach of Children.

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

Structured Label Content

Uses

Hand antiseptic to decrease bacteria on the skin.

Section 51945-4 (51945-4)

Purpose

Hand Antiseptic

Warnings

Flammable, For external use only.

Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly with water.

Discontinue use if irritation and redness develops.

Directions

Dispense an adequate amount (approx. 5 mL), rubbing all surfaces of both hands for at least 15 seconds.
Allow to dry without wiping.

Active Ingredient

Ethanol (62%)

Inactive Ingredients

Deionized Water, Isopropanol, Hydrogenated Starch Hydrolysate, Carbomer, THP Ethylendiamine, Fragrance

Principal Display Panel

NDC 64064-002-04

Instant Hand

Sanitizer

No Rinsing

Desinfectant

Instantane Pour Les Mains

Sans Rincage

Clinishield

Manufactured in U.S.A.

Fabrique Aux E.-U.

Evonik Stockhausen, LLC

Greensboro, NC 27406

1-800-334-0242 www.CliniShield.com

Imported by

Trans Canada Distribution Inc.

Mississauga, ON L5L 5Y7

Net Contents 32.82 Fl Oz

(1000 mL)

Contenu Net 1 L

Stock No. 31795

No. De Stock 31795

Stop Use and Ask Doctor If (Stop use and ask doctor if)

Skin or eye irritation persists for more than 72 hours

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": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Isopropyl Alcohol", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Edetol", "unii": "Q4R969U9FR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Carbomer Homopolymer Type C", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand antiseptic to decrease bacteria on the skin.", "Purpose": "Hand Antiseptic", "Warnings": "Flammable, For external use only. Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly with water. Discontinue use if irritation and redness develops.", "Directions": "Dispense an adequate amount (approx. 5 mL), rubbing all surfaces of both hands for at least 15 seconds. Allow to dry without wiping.", "Active Ingredient": "Ethanol (62%)", "Inactive Ingredients": "Deionized Water, Isopropanol, Hydrogenated Starch Hydrolysate, Carbomer, THP Ethylendiamine, Fragrance", "Principal Display Panel": "NDC 64064-002-04 Instant Hand Sanitizer No Rinsing Desinfectant Instantane Pour Les Mains Sans Rincage Clinishield Manufactured in U.S.A. Fabrique Aux E.-U. Evonik Stockhausen, LLC Greensboro, NC 27406 1-800-334-0242 www.CliniShield.com Imported by Trans Canada Distribution Inc. Mississauga, ON L5L 5Y7 Net Contents 32.82 Fl Oz (1000 mL) Contenu Net 1 L Stock No. 31795 No. De Stock 31795", "Stop use and ask doctor if": "Skin or eye irritation persists for more than 72 hours", "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: 2026-02-15T11:55:22.110837 · Updated: 2026-03-14T22:52:54.626056