drug facts

drug facts
SPL v1
SPL
SPL Set ID 9e8f69ab-f2f3-445d-89a4-6d337a11ff42
Route
topical
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chloroxylenol (5 mg)
Inactive Ingredients
water potassium cocoate hexylene glycol sodium sulfate anhydrous edetate sodium sodium lauryl sulfate glycerin anhydrous citric acid coco-glucoside glyceryl oleate methylchloroisothiazolinone fd&c yellow no. 5 methylisothiazolinone fd&c red no. 4

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-30

Purpose

Antiseptic handwash

Description

Chloroxylenol, 0.5%


Medication Information

Warnings
  • For external use only
Uses
  • For handwashing to decrease bacteria on the skin.
Purpose

Antiseptic handwash

Directions
  • Wet hands and forearms. • Apply palmful to hands and forearms. •  Scrub Thoroughly. •  Rinse and dry.
Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical emergency: (877) 231-2615 or call collect 0 (952) 853-1713
Description

Chloroxylenol, 0.5%

Questions?

Questions? Call 1-800-529-5458

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), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, citric acid, coco-glucoside, glyceryl oleate, fragrance, methylchloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FD&C Red. No. 4)

Do Not Use
  • In eyes
Active Ingredient

Chloroxylenol, 0.5%

When Using This Product
  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop
Stop Use and Ask Doctor If

Skin irritation or redness occurs for more than 72 hours

Principal Display Panel/representative Label

NDC 63146-111-10

Kay



QSR

Foaming Antibacterial Hand Soap

Instant foam lathers fast • Mild, pH-balanced formula • Fresh, clean fragrance

QSR Foaming Antibacterial Hand Soap is a rich lather hand soap with a  balanced blend of cleaning agents and skin protecting  moisturizers.

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

Chloroxylenol 0.5%

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

©2014 Kay Chemical Company | All rights reserved

756220-01 • KUSA 756220/8001/0214


Structured Label Content

Warnings
  • For external use only
Uses
  • For handwashing to decrease bacteria on the skin.
Purpose

Antiseptic handwash

Directions
  • Wet hands and forearms. • Apply palmful to hands and forearms. •  Scrub Thoroughly. •  Rinse and dry.
Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical emergency: (877) 231-2615 or call collect 0 (952) 853-1713
Questions?

Questions? Call 1-800-529-5458

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), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, citric acid, coco-glucoside, glyceryl oleate, fragrance, methylchloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FD&C Red. No. 4)

Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Chloroxylenol, 0.5%

When Using This Product (When using this product)
  • If in eyes, rinse promptly and thoroughly 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 occurs for more than 72 hours

Principal Display Panel/representative Label (Principal Display Panel/Representative Label)

NDC 63146-111-10

Kay



QSR

Foaming Antibacterial Hand Soap

Instant foam lathers fast • Mild, pH-balanced formula • Fresh, clean fragrance

QSR Foaming Antibacterial Hand Soap is a rich lather hand soap with a  balanced blend of cleaning agents and skin protecting  moisturizers.

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

Chloroxylenol 0.5%

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

©2014 Kay Chemical Company | All rights reserved

756220-01 • KUSA 756220/8001/0214


Advanced Ingredient Data


Raw Label Data

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