FOAMFRESH E-2 SANITIZER CLEANSER WITH PCMX- 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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Active Ingredient

Chloroxylenol 0.50%

Purpose

Antimicrobial

Uses:

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

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

Directions:

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Rinse with potable water.

Inactive Ingredients:

Water, Sodium Lauryl Ether Sulfate, Decyl Glucoside, Cocamidopropyl Betaine, Propylene Glycol, Glycerine, Preservative

FoamFresh

E-2 Sanitizer Cleanser

with PCMX

NSF

Nonfood Compounds

Program Listed (E2)

(Registration #xxxxxx)

WOODBINE

Products Company

915 West Smith Road Medina, OH 44256

800.824.8179 woodbineproducts.com

Stock # 4360P 1000 ml (34 fl. oz.)

Made in the U.S.A.

container label

FOAMFRESH E-2 SANITIZER CLEANSER WITH PCMX
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11429-1011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11429-1011-3	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/12/2021	11/04/2022

Labeler - Woodbine Products Company (004220323)

Name	Address	ID/FEI	Business Operations
Establishment
Woodbine Products Company		004220323	manufacture(11429-1011)

Revised: 11/2022

Document Id: eca7c5e1-8656-4c0e-e053-2995a90a01dd

Set id: ce26a8e9-ff4d-3a73-e053-2a95a90a0f3d

Version: 2

Effective Time: 20221104

Woodbine Products Company