FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH- chloroxylenol solution

FoamFresh Dye Free Antibacterial Hand Wash by

Drug Labeling and Warnings

FoamFresh Dye Free Antibacterial Hand Wash by is a Otc medication manufactured, distributed, or labeled by Woodbine Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Chloroxylenol 0.25%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Uses:

For hand washing to decrease bacteria on the skin.

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions:

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

STORAGE AND HANDLING

Other Information:

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

INACTIVE INGREDIENT

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

FOAMFresh

DYE FREE

ANTIBACTERIAL

Hand WASH

Sense the

Difference

Stock # 5110DF

1250 ml (42 fl.oz.)

INGREDIENTS AND APPEARANCE

FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH 
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11429-1010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11429-1010-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/20/2018
2	NDC: 11429-1010-7	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/20/2018
3	NDC: 11429-1010-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/20/2018
4	NDC: 11429-1010-8	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/20/2018

Labeler - Woodbine Products Company (004220323)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(11429-1010)