FOAMFRESH HEALTHCARE 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 0.75%

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 efficacy, 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 Ingredients:

Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Polysorbate 20, Decyl Glucoside, Potassium Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol and Fragrance.

FoamFresh

Healthcare Hand Wash

Fortified with moisturizers, for maximum skin

conditioning. Suitable for everyday use in

medical facilities.

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

www.woodbineproducts.com

Made in the U.S.A.

Stock # 4395 1000 ml (34 fl. oz.)

container label

FOAMFRESH HEALTHCARE HAND WASH
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11429-1008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	7.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11429-1008-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/18/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/18/2014	11/04/2022

Labeler - Woodbine Products Company (004220323)

Name	Address	ID/FEI	Business Operations
Establishment
Woodbine Products Company		004220323	manufacture(11429-1008)

Revised: 11/2022

Document Id: eca81132-4dfe-bc3b-e053-2a95a90ae24c

Set id: 470eaba5-b6b8-4c7a-9936-b0146c2856af

Version: 3

Effective Time: 20221104

Woodbine Products Company