STRIKE BAC ANTIBACTERIAL HANDSOAP- chloroxylenol gel 
Genlabs Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Strike Bac Antibacterial Handsoap

Drug Facts

Active ingredients

Chloroxylenol 0.25%

Purpose

Antiseptic

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 or 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, D&C Red # 33, Fragrance, Glycerin, Glycol Distearate, 2-Methyl-4-Isothiazolin-3-One, Sodium Chloride, Sodium Laureth Sulfate, Water.

Strike Bac Antibacterial Handsoap

image description

STRIKE BAC ANTIBACTERIAL HANDSOAP 
chloroxylenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62569-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62569-003-001 in 1 CARTON02/08/2023
1473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/08/202307/15/2024
Labeler - Genlabs Corporation (064594260)
Registrant - Genlabs Corporation (064594260)
Establishment
NameAddressID/FEIBusiness Operations
Morgan Gallacher028311595manufacture(62569-003)

Revised: 1/2024
Document Id: ab0388c9-2682-4b06-9294-019e3490ce89
Set id: 38467a1c-e4e2-4d7f-a40d-e5408a5355ab
Version: 2
Effective Time: 20240110
 
Genlabs Corporation