Kay: Package Insert and Label Information

KAY- benzalkonium chloride solution
Kay Chemical Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Benzalkonium chloride 0.1%

Purpose

Antiseptic handwash

Uses

  • For handwashing to decrease bacteria on the skin

Warnings

For external use only

Do not use

  • In eyes

When using this product

  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop

Stop use and ask a doctor if

  • skin irritation and redness occurs for more than 72 hours

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

Directions

  • wash hands to remove soil
  • dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry

Other Information

  • for additional information, see Safety Data Sheet (SDS)
  • Medical emergency: (877) 231-2615 or call collect 0 (952) 853-1713

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

Questions? Call 1-800-529-5458

Principal Display panel and representative label

NDC 63146-109-10

KAY

Foaming Hand Sanitizer

KEEP OUT OF REACH OF CHILDREN — FOR INSTITUTIONAL USE ONLY

Benzalkonium chloride 0.1%

Net contents: 42 US fl oz (1250 ml)

Distributed by:

Kay Chemical Company • 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2018 Kay Chemical Company

All rights reserved

757547-02 • KUSA 757547/8002/0618

representative label
(click image for full-size original)
KAY
benzalkonium chloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63146-109
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
FD&C RED NO. 40
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63146-109-03 750 mL in 1 BOTTLE, PLASTIC None
2 NDC:63146-109-06 1200 mL in 1 BOTTLE, PLASTIC None
3 NDC:63146-109-10 1250 mL in 1 BOTTLE, PLASTIC None
4 NDC:63146-109-08 750 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 02/22/2008
Labeler — Kay Chemical Company (003237021)

Revised: 11/2022 Kay Chemical Company

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