FOAMFRESH ALCO-FOAM HAND SANITIZER- alcohol liquid

FoamFresh Alco-Foam Hand Sanitizer by

Drug Labeling and Warnings

FoamFresh Alco-Foam 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

Ethyl Alcohol 62% v/v

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses:

For hand sanitizing to decrease bacteria on the skin that could cause disease.

Recommended for repeated use.

WARNINGS

Warnings:

Flammable. Keep away from fire or flame

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.

DOSAGE & ADMINISTRATION

Directions:

Place enough product in your palm to thoroughly cover your hands.

Rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

STORAGE AND HANDLING

Other information:

Store below 110 F (43 C).

May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT

Inactive ingredients:

Water, DEA-C8-18 Perfluoroalkylethyl Phosphate

PRINCIPAL DISPLAY PANEL

Alco-Foam

Hand Sanitizer

Decreases common germs that

can cause illness. Leaves skin

soft and refreshed.

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

www.woodbineproducts.com

Made in the USA

Stock # 4640         900 ml (31 fl. oz.)

FoamFresh Alco-Foam

Sanitizer

INGREDIENTS AND APPEARANCE

FOAMFRESH ALCO-FOAM HAND SANITIZER  
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11429-1004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11429-1004-1	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
2	NDC: 11429-1004-2	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
3	NDC: 11429-1004-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
4	NDC: 11429-1004-4	900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
5	NDC: 11429-1004-5	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
6	NDC: 11429-1004-6	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
7	NDC: 11429-1004-7	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
8	NDC: 11429-1004-8	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2014

Labeler - Woodbine Products Company (004220323)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(11429-1004)