FOAMFRESH ALCO-FREE HAND SANITIZER- benzalkonium chloride 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

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses:

For hand sanitizing 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 conditions 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:

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.

Inactive Ingredients:

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid, Fragrance.

FoamFresh

Alco-Free Hand Sanitizer

Formulated to reduce the number of germs on the hands that can cause infection and illness

Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere

Use on clean, non-soiled hands any time when rinsing with water is not available

Kills 99.99% of common germs that can cause disease

PK

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

wwww.woodbineproducts.com

Made in the U.S.A.

Stock # 4350         1000 ml (34 fl. oz.)

container label

FOAMFRESH ALCO-FREE HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11429-1001-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
2NDC:11429-1001-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
3NDC:11429-1001-41500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
4NDC:11429-1001-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
5NDC:11429-1001-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
6NDC:11429-1001-91100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2014
7NDC:11429-1001-01125 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/16/2014
Labeler - Woodbine Products Company (004220323)
Establishment
NameAddressID/FEIBusiness Operations
Woodbine Products Company004220323manufacture(11429-1001)

Revised: 6/2022
Document Id: e1a57a3d-1109-2244-e053-2995a90abd14
Set id: 59614a1a-6b76-45e7-8b57-af307a1673cf
Version: 3
Effective Time: 20220617
 
Woodbine Products Company