SECURE - chloroxylenol aerosol, foam 
Brands International

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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Secure Antibacterial Foam



Active Ingredient   chloroxylenol 0.5%    antiseptic



Antiseptic



Keep out of reach of children.



Use: For handwashing to decrease bacteria on the skin.


Warnings:
For external use only

Keep out of reach of children

Avoid eye contact. Should contact occur, rinse thoroughly with water.

If swallowed or irritation develops, discontinue use and consult a health care practitioner.


Directions:

Wet hands and forearms with hot water. Apply soap. Rub hands together for 23 seconds. Clean under fingernails. Rinse thoroughly under running water. Dry hands.


Inactive Ingredients:
water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Cocamide DEA, Glycerin, Fragrance, Citric Acid, DMDM Hydantoin, Yellow 5, Red 4



label


Butler Chemicals Inc

Secure Antibacterial Foam Soap

Butler Chemicals, Inc

PH: 800-331-3643www.butlerchem.com

Chloroxylenol 0.5%  Made in Canada

SECURE 
chloroxylenol aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-200-01100 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2011
Labeler - Brands International (243748238)
Registrant - Butler Chemicals (165322223)
Establishment
NameAddressID/FEIBusiness Operations
Brands International243748238manufacture

Revised: 4/2012
Document Id: d9f0b9a3-32ba-4bdd-bf90-00d22099dfb7
Set id: 20f6efdd-4e10-4baa-9fb3-335460cc2fd8
Version: 1
Effective Time: 20120424
 
Brands International