FOAMFRESH ALCO-FOAM HAND SANITIZER- alcohol 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 1004

Active Ingredient

Ethyl Alcohol 62% v/v

Purpose

Antimicrobial

Uses:

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

Recommended for repeated use.

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.

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.

Other information:

Store below 110 F (43 C).

May discolor certain fabrics or surfaces.

Inactive ingredients:

Water, DEA-C8-18 Perfluoroalkylethyl Phosphate

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

container label

FOAMFRESH ALCO-FOAM HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11429-1004-159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
2NDC:11429-1004-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
3NDC:11429-1004-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
4NDC:11429-1004-4900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
5NDC:11429-1004-51500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
6NDC:11429-1004-63785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
7NDC:11429-1004-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
8NDC:11429-1004-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
9NDC:11429-1004-0400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2014
Labeler - Woodbine Products Company (004220323)
Establishment
NameAddressID/FEIBusiness Operations
Woodbine Products Company004220323manufacture(11429-1004)

Revised: 6/2022
Document Id: e1a5a6ff-8045-62fd-e053-2a95a90a160f
Set id: 2e9c752c-ad69-4692-a17a-e98b84c7e9a5
Version: 3
Effective Time: 20220617
 
Woodbine Products Company