GENLABS STRIKE BAC ANTIBACTERIAL HANDSOAP - chloroxylenol soap
Genlabs Corporation

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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Genlabs Strike Bac Antibacterial Handsoap

Drug Facts

Active Ingredient

Chloroxylenol 0.25%

Purpose

Antiseptic

Use

for handwashing to decrease bacteria on the skin
recommended for repeated use

Warnings

For external use only

Do not use in the eyes. In case of contact, flush thoroughly with water.

Stop use and ask a doctor if irritation and redness develop, or if condition persists 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 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 15 seconds. Rinse and repeat.

Inactive Ingredients

5-Chloro-2-Methyl-4-Isothiazolin-3-One, Cocamide MIPA, Cocamidopropyl Betaine, DandC Red # 33, Fragrance, Glycerin, Glycol Distearate, 2-Methyl-4-Isothiazolin-3-One, Sodium Chloride, Sodium Laureth Sulfate, Water.

Strike Bac Antibacterial Handsoap

Strike Bac Antibacterial Handsoap is the ideal liquid hand soap because its antibacterial formula kills germs on contact and will effectively remove bacteria from the hands. Before using, consult supplier for further information and precautions, including Material Safety Data Sheets.

Manufactured By: Genlabs 5568 Schaefer Ave., Chino, CA 91710 (909) 591-8451

Genlabs Strike Bac Antibacterial Handsoap 3.78L (62569-000-00)

StrikeBacLabel

GENLABS STRIKE BAC ANTIBACTERIAL HANDSOAP
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:62569-000
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (CHLOROXYLENOL)	CHLOROXYLENOL	2.5 mg in 0.001 L

Ingredient Name	Strength
Inactive Ingredients
METHYLCHLOROISOTHIAZOLINONE
COCO MONOISOPROPANOLAMIDE
COCAMIDOPROPYL BETAINE
D&C RED NO. 33
GLYCERIN
GLYCOL DISTEARATE
METHYLISOTHIAZOLINONE
SODIUM CHLORIDE
SODIUM LAURETH SULFATE
WATER

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62569-000-00	3.78 L in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/29/2013

Labeler - Genlabs Corporation (064594260)

Registrant - Genlabs Corporation (064594260)

Name	Address	ID/FEI	Business Operations
Establishment
Genlabs Corporation		064594260	manufacture(62569-000)

Revised: 10/2013

Document Id: 5bb2d36c-06b4-49fd-9f70-fda9754125b7

Set id: 06b5a13c-7b58-4ac4-a598-a5ae1cc5fa9e

Version: 2

Effective Time: 20131009

Genlabs Corporation