LAGARDE- chloroxylenol solution

Lagarde by

Drug Labeling and Warnings

Lagarde by is a Otc medication manufactured, distributed, or labeled by Kay Chemical Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chloroxylenol 0.5%

Purpose

Antiseptic handwash

Uses

• For handwashing 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 throughly for 20 seconds
• Rinse and repeat
  

Other information

• for additional information, see Material Safety Data Sheet (MSDS)
• for emergency medical information in USA, call 1-800-391-1504
  

Inactive ingredients

water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C Red #40, FD&C Yellow #5, D&C Red #33

Principal display panel and representative label

NDC: 63149-121-01

LAGARDE™

Antibacterial Hand Soap

Active ingredient

Chloroxylenol 0.5%

SSDC Sustainable Solutions

1 US gallon (3.78 liters)

Distributed by: SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100  Grapevine, Texas 76051, USA  800.532.7732

©2013 Kay Chemical Company  All Rights Resevrved

1111917

747932-01 747932/7300/0613

INGREDIENTS AND APPEARANCE

LAGARDE 
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63146-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63146-121-01	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016
2	NDC: 63146-121-02	800 mL in 1 POUCH; Type 0: Not a Combination Product	05/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/31/2016

Labeler - Kay Chemical Co. (003237021)