FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH - chloroxylenol solution 
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 vigorous for 30 seconds, rinse and dry.

Other Information:

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

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Decyl Glucoside. Potassiom Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol and Fragrance

FOAMFresh

DYE FREE

ANTIBACTERIAL

Hand WASH

Sense the

Difference

Stock # 5110DF

1250 ml (42 fl.oz.)

container label

FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH 
chloroxylenol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11429-1010-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/2018
2NDC:11429-1010-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/2018
3NDC:11429-1010-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/2018
4NDC:11429-1010-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/20/2018
Labeler - Woodbine Products Company (004220323)
Establishment
NameAddressID/FEIBusiness Operations
Woodbine Products Company004220323manufacture(11429-1010)

Revised: 11/2018
Document Id: 9fa71be6-bc0e-4179-9881-e611f4d0e2d8
Set id: ba205f78-6e3f-483e-a37a-537f6917b00c
Version: 1
Effective Time: 20181120
 
Woodbine Products Company