FORTRESS- 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 5 mg in 1 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

FORTRESS- 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
Dispense a palmful of product to hands
Scrub hands and forearms for 20 seconds
Rinse thoroughly and dry
OTHER INFORMATION
for additional information, see Material Safety Data Sheet (MSDS)
for additional information, see Material Safety Data Sheet (MSDS)
for emergency medical information in USA, call [phone] or call
collect 0 (952)
853-1713
INACTIVE INGREDIENTS: water (aqua), potassium cocoate, hexylene
glycol, sodium
sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, citric
acid, coco-glucoside,
glyceryl oleate, fragrance, methychloroisothiazolinone, CI 19140 (FD&C
Yellow No. 5),
methylisothiazolinone, CI 14700 (FDC Red No. 4)
QUESTIONS? Call 1-800-529-5458
PRINCIPAL DISPLAY PANEL AND REPRESENTATIVE LABEL
FORTRESS® FOAMING ANTIBACTERIAL HAND SOAP
KEEP OUT OF REACH OF CHILDREN/FOR INSTITUTIONAL USE ONLY
FORTRESS® Foaming Antibacterial Hand Soap is a rich lather hand soap
with a
balanced blend of cleaning agents and skin protecting moisturizers.
Instant foam lathers fast • Mild, pH-balanced formula
Fresh, clean fragrance
To obtain Spanish instructions, see outer carton.
Para obtener las instrucciones en español, véase la caja exterior.
NDC.: 63146-105-03
KAY CHEMICAL COMPANY
8300 Capital Drive
Greensb