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

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 skin and spread a small amount on hands and forearms
  • Scrub well, 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. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US)
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 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

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
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

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

Antiseptic handwash

Directions
  • Wet skin and spread a small amount on hands and forearms
  • Scrub well, 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. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US)
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

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
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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