drug facts

drug facts
SPL v6
SPL
SPL Set ID f0f3d88b-70be-4216-9149-a30ba491b44a
Route
topical
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chloroxylenol (0.5 mg)
Inactive Ingredients
water potassium cocoate hexylene glycol sodium sulfate edetate sodium sodium lauryl sulfate glycerin citric acid monohydrate 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 2011-04-05

Purpose

Antiseptic handwash

Description

Chloroxylenol, 0.5%


Medication Information

Warnings

For external use only

Uses
  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use
Purpose

Antiseptic handwash

Directions
  • wet hands and forearms
  • dispense a palmful of product to hands
  • scrub hands and forearms for 20 seconds
  • rinse thoroughly and dry
Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1.800.328.0026
Description

Chloroxylenol, 0.5%

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 (FDC Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)

Section 53413-1

Questions? call 1.800.35.CLEAN (352.5326)

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 A Doctor If
  • skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

Sysco   Reorder #

Reliance   0279754

AB FOAM HAND SOAP

ACTIVE INGREDIENT: CHLOROXYLENOL 0.5%

DISTRIBUTED BY SYSCO CORPORATION

HOUSTON, TEXAS 77077

001123   6100592

751544/5404/1122

NET CONTENTS: 25.4 US FL OZ (750 mL)


Structured Label Content

Warnings

For external use only

Uses
  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use
Purpose

Antiseptic handwash

Directions
  • wet hands and forearms
  • dispense a palmful of product to hands
  • scrub hands and forearms for 20 seconds
  • rinse thoroughly and dry
Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1.800.328.0026
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 (FDC Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)

Section 53413-1 (53413-1)

Questions? call 1.800.35.CLEAN (352.5326)

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 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)

Sysco   Reorder #

Reliance   0279754

AB FOAM HAND SOAP

ACTIVE INGREDIENT: CHLOROXYLENOL 0.5%

DISTRIBUTED BY SYSCO CORPORATION

HOUSTON, TEXAS 77077

001123   6100592

751544/5404/1122

NET CONTENTS: 25.4 US FL OZ (750 mL)


Advanced Ingredient Data


Raw Label Data

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