Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ecd4f3fa-4d31-40d9-acc5-b5f258f3aed0
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 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

Description

Chloroxylenol 0.5%

Purpose

Antiseptic Handwash


Medication Information

Purpose

Antiseptic Handwash

Description

Chloroxylenol 0.5%

Uses
  • For handwashing to decrease bacteria on the skin.

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, methychloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)

Section 53413-1

Questions?  Call (800) 654-8030

Warnings
  • For external use only

Directions
  • Wet hands and forearms • Apply palmful to hands and forearms.
  • Scrub thoroughly • Rinse and dry.
Do Not Use
  • In eyes
Active Ingredient

Chloroxylenol 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (800) 391-1504
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 or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

Rushing

1110840

Foaming Antibacterial Hand Soap

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%

To obtain Spanish Instructions, see outer carton.

Net contents: 42 US fl oz (1250 ml)                           NDC 63146-308-10

Distributed by | Distribuido por:

SSDC · 4050 Corporate Dr., #100

Grapevine, Texas 76051-2326 USA

Customer Service: (800) 654-8030

©2018 | All rights reserved | Todas los derechos reservados

Made in USA | Hecho en Estados Unidos

774260-00 · RSHGUSA 774260/8000/0918


Structured Label Content

Uses
  • For handwashing to decrease bacteria on the 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), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, citric acid, coco-glucoside, glyceryl oleate, fragrance, methychloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)

Section 53413-1 (53413-1)

Questions?  Call (800) 654-8030

Purpose

Antiseptic Handwash

Warnings
  • For external use only

Directions
  • Wet hands and forearms • Apply palmful to hands and forearms.
  • Scrub thoroughly • Rinse and dry.
Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Chloroxylenol 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (800) 391-1504
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 A Doctor If (Stop use and ask a doctor if)
  • Skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label (Principal display panel and representative label)

Rushing

1110840

Foaming Antibacterial Hand Soap

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%

To obtain Spanish Instructions, see outer carton.

Net contents: 42 US fl oz (1250 ml)                           NDC 63146-308-10

Distributed by | Distribuido por:

SSDC · 4050 Corporate Dr., #100

Grapevine, Texas 76051-2326 USA

Customer Service: (800) 654-8030

©2018 | All rights reserved | Todas los derechos reservados

Made in USA | Hecho en Estados Unidos

774260-00 · RSHGUSA 774260/8000/0918


Advanced Ingredient Data


Raw Label Data

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