FOAMFRESH ANTIBACTERIAL HAND WASH  - chloroxylenol liquid 
Woodbine Products Company

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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Drug Facts

Active Ingredient

Chloroxylenol 0.25%

Purpose

Antibacterial

Uses:

For hand washing to decrease bacteria on the skin.

Warnings:

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For maximum efficiency, pump foam into dry hands, lather vigorously for 30 seconds, rinse and dry.

Other Information:

Store at 20 to 25 C. (68 to 77 F)

Inactive Ingredient:

Water, Sodium Lauryl Sulfate, C10-16 Alkyl Glucoside, Cocamidopropyl Betaine, Lauryl Glucoside, Potassium Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol, Fragrance and FDC Blue #1, FDC Yellow #5, FDC Yellow #6.

FoamFresh

Antibacterial Hand Wash

The easiest way to clean

hands. A fragranced, luxuriant foam,

it is easily dispensed for an enjoyable

hand wash. Sense the difference.

Woodbine Products Company

915 West Smith Road

Medina, OH 44256

www.woodbineproducts.com

Made in USA

Stock #4510                    1000 ml. (34 fl. oz.)

FoamFresh Antibacterial

Fortified with Collagen

container label

FOAMFRESH ANTIBACTERIAL HAND WASH  
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11429-1005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
LAURYL GLUCOSIDE 
DMDM HYDANTOIN 
PROPYLENE GLYCOL 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11429-1005-159 mL in 1 BOTTLE, PLASTIC
2NDC:11429-1005-2250 mL in 1 BOTTLE, PLASTIC
3NDC:11429-1005-31000 mL in 1 BOTTLE, PLASTIC
4NDC:11429-1005-42125 mL in 1 BOTTLE, PLASTIC
5NDC:11429-1005-53785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/28/2012
Labeler - Woodbine Products Company (004220323)
Establishment
NameAddressID/FEIBusiness Operations
Woodbine Products Company004220323manufacture(11429-1005)

Revised: 9/2012
Document Id: cce6f2b7-5360-4f5c-95f5-106612d7e47d
Set id: c77d28bd-b2e2-42f5-a8b5-7c72c99eb8fa
Version: 1
Effective Time: 20120928
 
Woodbine Products Company