FoamFresh E-2 Sanitizer Cleanser with PCMX by Woodbine Products Company

FoamFresh E-2 Sanitizer Cleanser with PCMX by

Drug Labeling and Warnings

FoamFresh E-2 Sanitizer Cleanser with PCMX by is a Otc medication manufactured, distributed, or labeled by Woodbine Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

W

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 11429-1011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11429-1011-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/12/202111/04/2022
Labeler - Woodbine Products Company (004220323)
Establishment
NameAddressID/FEIBusiness Operations
Woodbine Products Company004220323manufacture(11429-1011)

Revised: 11/2022