LAGARDE- chloroxylenol solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)

Available from:

Kay Chemical Co.

INN (International Name):

CHLOROXYLENOL

Composition:

CHLOROXYLENOL 0.5 mg in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic handwash - For handwashing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

LAGARDE- CHLOROXYLENOL SOLUTION
KAY CHEMICAL CO.
_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._
----------
DRUG FACTS
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
LAGARDE
chloroxylenol solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63146-121
ROUTE OF ADMINISTRATION
TOPICAL
Kay Chemical Co.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CH