FOAMFRESH ALCO-FREE HAND SANITIZER- benzalkonium chloride liquid

FoamFresh Alco-Free Hand Sanitizer by

Drug Labeling and Warnings

FoamFresh Alco-Free Hand Sanitizer 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

Benzalkonium Chloride 0.1%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses:

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

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 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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

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.)

INGREDIENTS AND APPEARANCE

FOAMFRESH ALCO-FREE HAND SANITIZER  
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11429-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11429-1001-2	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2018
2	NDC: 11429-1001-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2018
3	NDC: 11429-1001-4	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2018
4	NDC: 11429-1001-7	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2018
5	NDC: 11429-1001-8	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/16/2014

Labeler - Woodbine Products Company (004220323)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(11429-1001)