ALCO HAND SANITIZER- alcohol gel 
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 1003

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Sanitizer

Uses:

For hand sanitizing to decrease bacteria on the skin.

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:

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.

Other Information:

Store below 110 F (43 C).

May discolor certain fabrics or surfaces.

Inactive Ingredients:

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

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.)

container label

ALCO HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11429-1003-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
2NDC:11429-1003-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
3NDC:11429-1003-41500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
4NDC:11429-1003-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
5NDC:11429-1003-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
6NDC:11429-1003-51892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2020
7NDC:11429-1003-63785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2020
8NDC:11429-1003-2355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/10/2014
Labeler - Woodbine Products Company (004220323)
Establishment
NameAddressID/FEIBusiness Operations
Woodbine Products Company004220323manufacture(11429-1003)

Revised: 6/2022
Document Id: e1a59825-ee52-62ff-e053-2a95a90a08cd
Set id: 3bd696e2-9125-4604-ace9-d931d9fb5ea3
Version: 4
Effective Time: 20220617
 
Woodbine Products Company