Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 74373f6b-f407-455e-93a1-b0fd31e40718
Route
TOPICAL
Published
Effective Date 2024-07-11
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 Sodium Citrate Glyceryl Oleate Sodium Glycolate Decyl Glucoside Lauryl Glucoside Magnesium Nitrate Sodium Hydroxide Methylchloroisothiazolinone Magnesium Chloride Fd&c Yellow No. 5 Methylisothiazolinone Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-27

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
  • Recommended for repeated use
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, sodium citrate, glyceryl oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, lauryl glucoside, magnesium nitrate, sodium hydroxide, methylchloroisothiazolinone, magnesium chloride, yellow 5, methylisothiazolinone, red 4

Section 53413-1

Questions?  call  1 866 781 8787

Warnings
For external use only
Directions
  • wet skin and spread a small amount on hands and forearms
  • scrub well, rinse thoroughly and dry
Do Not Use
  • In eyes
Active Ingredient

Chloroxylenol 0.5%

Other Information
  • for additional infomration see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1 800 328 0026.  If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US)
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

NDC 47593-503-59

ECOLAB

MEDI-STAT® Foam

Antimicrobial Hand Soap

Active Ingredient:  Chloroxylenol 0.5%

Net Contents:  1250 mL (42.3 fl oz)

6000107

Ecolab · 1 Ecolab Place · St Paul MN 55102 USA

© 2022 Ecolab USA Inc · All rights reserved

Made in United States

755670/8502/0422


Structured Label Content

Uses
  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use
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, sodium citrate, glyceryl oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, lauryl glucoside, magnesium nitrate, sodium hydroxide, methylchloroisothiazolinone, magnesium chloride, yellow 5, methylisothiazolinone, red 4

Section 53413-1 (53413-1)

Questions?  call  1 866 781 8787

Purpose

Antiseptic handwash

Warnings
For external use only
Directions
  • wet skin and spread a small amount on hands and forearms
  • scrub well, rinse thoroughly and dry
Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Chloroxylenol 0.5%

Other Information (Other information)
  • for additional infomration see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1 800 328 0026.  If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US)
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)

NDC 47593-503-59

ECOLAB

MEDI-STAT® Foam

Antimicrobial Hand Soap

Active Ingredient:  Chloroxylenol 0.5%

Net Contents:  1250 mL (42.3 fl oz)

6000107

Ecolab · 1 Ecolab Place · St Paul MN 55102 USA

© 2022 Ecolab USA Inc · All rights reserved

Made in United States

755670/8502/0422


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)