PUREFORCE- chloroxylenol solution
Ecolab Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Chloroxylenol 0.5%

Purpose

Antiseptic handwash

Uses

For handwshing to decrease bacteria on the skin

Warnings

For external use only

Do not use

In eyes

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands and forearms
Apply 5 ml (teaspoonful) or palmful to hands and forearms
Scrub thoroughly for 20 seconds
Rinse and repeat

Other information

for additional information, see Material Safety Data Sheet (MSDS)
for emergency medical information in USA and Canada, call 1-800-328-0026

Inactive ingredients water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium laryl sulfate, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FDC Red 40, FDC Yellow 5, DC Red 33

Principal Display Panel and Representative Label

Economy

Antibacterial

Hand Soap

Active Ingredient: Chloroxylenol 0.5%

8000151

Net Contents: 27 US fl oz / 800 mL

For questions or comments, call 1-866-444-7450.

Distributed by:

PureForce

370 Wabasha Street North

St. Paul, MN 55102

Made in U.S.A.

718809/7100/0812

representative label

PUREFORCE
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47593-497
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POTASSIUM COCOATE (UNII: F8U72V8ZXP)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM SULFATE (UNII: 0YPR65R21J)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
glycerin (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47593-497-25	800 mL in 1 BAG; Type 0: Not a Combination Product	07/27/2012	02/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/27/2012	02/16/2018

Labeler - Ecolab Inc. (006154611)

Name	Address	ID/FEI	Business Operations
Establishment
Kay Chemical Co.		003237021	analysis(47593-497) , label(47593-497) , manufacture(47593-497) , pack(47593-497) , relabel(47593-497) , repack(47593-497)

Revised: 2/2018

Document Id: a536f17f-fc6a-4058-9c0c-b99b3dfd050e

Set id: f6fbd3ff-0426-4534-8a08-26a253b9752b

Version: 2

Effective Time: 20180216

Ecolab Inc.