Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID b4493ad6-e1c8-4b2d-8a57-1845589b04f9
Route
TOPICAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (5.20 mg)
Inactive Ingredients
Water Potassium Cocoate Hexylene Glycol Sodium Sulfate Edetate Sodium Sodium Lauryl Sulfate Hydroxyethyl Cellulose (3000 Cps At 1%) Glycerin Coco Glucoside Glyceryl Oleate Citric Acid Monohydrate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Red No. 40 Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-10-24 Until 2023-05-18

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 50569-3

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Section 51727-6

Inactive ingredients  water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, frangrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C red #40, FD&C yellow #5, D&C red #33

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 information, 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
Principal Display Panel and Representative Label

NDC 47593-501-41   ECOLAB

Medi-Stat

Antimicrobial Hand Soap

Healthcare Personnel Handwash

Active Ingredient: Chloroxylenol 0.5%

6000077

Net Contents:

25 US fl oz (750 mL)

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA

© 2022 Ecolab USA Inc · All rights reserved

Made in United States

www.ecolab.com · 755056/8501/0422


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 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Section 51727-6 (51727-6)

Inactive ingredients  water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, frangrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C red #40, FD&C yellow #5, D&C red #33

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 information, 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
Principal Display Panel and Representative Label (Principal display panel and representative label)

NDC 47593-501-41   ECOLAB

Medi-Stat

Antimicrobial Hand Soap

Healthcare Personnel Handwash

Active Ingredient: Chloroxylenol 0.5%

6000077

Net Contents:

25 US fl oz (750 mL)

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA

© 2022 Ecolab USA Inc · All rights reserved

Made in United States

www.ecolab.com · 755056/8501/0422


Advanced Ingredient Data


Raw Label Data

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