Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 509b6671-000f-496c-80f2-96a354cc40fb
Route
TOPICAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 mg)
Inactive Ingredients
Water Isopropyl Alcohol Propylene Glycol Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-18
Description

Benzalkonium chloride 0.1%

Purpose

Antiseptic handwash

Medication Information

Indications and Usage
  • for handwashing to decrease bacteria on skin
Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.1%

Section 50565-1

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

Section 51727-6

Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, CI 16035 (FD&C Red 40), CI 42090 (FD&C Blue 1)

Section 53413-1

Questions? call 1-800-529-5458

Warnings

For external use only

Directions
  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry
Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 0.1%

Other Information
  • For additional information, see Safety Data Sheet (SDS)
  • For emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713
When Using This Product
  • if in eyes, rinse promptly and throughly with water
  • discontinue use if irritation and redness develop
Stop Use and Ask Doctor If 
  • skin irritation or redness persists for more than 72 hours
Principal Display Panel and Representative Label

CHEMSTAR

Foaming

Hand Sanitizer

Sanitizante de manos en espuma

KEEP OUT OF REACH OF CHILDREN

FOR INSTITUTIONAL USE ONLY

Benzalkonium chloride 0.1%

Net Contents: 42 US fl oz (1250 ml)

1111302

Distributed by:

Kay Chemical Company

8300 Capital Drive • Greensboro, NC 27409

Made in USA • CSUSA 778273/8000/0621

Structured Label Content

Indications and Usage (34067-9)
  • for handwashing to decrease bacteria on 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 51727-6 (51727-6)

Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, CI 16035 (FD&C Red 40), CI 42090 (FD&C Blue 1)

Section 53413-1 (53413-1)

Questions? call 1-800-529-5458

Purpose

Antiseptic handwash

Warnings

For external use only

Directions
  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry
Do Not Use (Do not use)
  • in eyes
Active Ingredient (Active ingredient)

Benzalkonium chloride 0.1%

Other Information
  • For additional information, see Safety Data Sheet (SDS)
  • For emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713
When Using This Product (When using this product)
  • if in eyes, rinse promptly and throughly with water
  • discontinue use if irritation and redness develop
Stop Use and Ask Doctor If  (Stop use and ask doctor if )
  • skin irritation or redness persists for more than 72 hours
Principal Display Panel and Representative Label (Principal Display Panel and Representative label)

CHEMSTAR

Foaming

Hand Sanitizer

Sanitizante de manos en espuma

KEEP OUT OF REACH OF CHILDREN

FOR INSTITUTIONAL USE ONLY

Benzalkonium chloride 0.1%

Net Contents: 42 US fl oz (1250 ml)

1111302

Distributed by:

Kay Chemical Company

8300 Capital Drive • Greensboro, NC 27409

Made in USA • CSUSA 778273/8000/0621

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:46.600370 · Updated: 2026-03-14T23:11:33.591824