ALCO HAND SANITIZER- alcohol gel

Alco Hand Sanitizer by

Drug Labeling and Warnings

Alco 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 70% v/v

PURPOSE

Purpose

Sanitizer

INDICATIONS & USAGE

Uses:

For hand sanitizing to decrease bacteria on the skin.

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:

Apply gel to dry hands and rub thoroughly until hands are dry.

Do not rinse or wipe gel off.

Should solution enter eyes, rinse immediately with water.

STORAGE AND HANDLING

Other Information:

Store below 110 F (43 C).

May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Propylene Glycol, PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Triethanolamine, Carbopol and Fragrance.

PRINCIPAL DISPLAY PANEL

Alco-Gel Hand Sanitizer

Evaporates quickly

Kills 99.99% of common germs that can cause illness

Leaves hands smooth and refreshed

PK

Woodbine Products Company

915 West Smith Road

Medina, Ohio 44256

www.woodbineproducts.com

Made in the U.S.A.

Stock # 4330        10000 ml (34 fl. oz.)

INGREDIENTS AND APPEARANCE

ALCO HAND SANITIZER  
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11429-1003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11429-1003-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
2	NDC: 11429-1003-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
3	NDC: 11429-1003-4	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
4	NDC: 11429-1003-7	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2018
5	NDC: 11429-1003-8	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	04/10/2014

Labeler - Woodbine Products Company (004220323)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(11429-1003)