Alco Hand Sanitizer: Package Insert and Label Information

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.

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.)

ALCO HAND SANITIZER alcohol gel

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER PROPYLENE GLYCOL POLYETHYLENE GLYCOL 1500 POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 700 TROLAMINE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:11429-1003-1 30 mL in 1 BOTTLE, PLASTIC None 2 NDC:11429-1003-3 1000 mL in 1 BOTTLE, PLASTIC None 3 NDC:11429-1003-4 1500 mL in 1 BOTTLE, PLASTIC None 4 NDC:11429-1003-7 750 mL in 1 BOTTLE, PLASTIC None 5 NDC:11429-1003-8 1250 mL in 1 BOTTLE, PLASTIC None 6 NDC:11429-1003-5 1892 mL in 1 BOTTLE, PLASTIC None 7 NDC:11429-1003-6 3785 mL in 1 BOTTLE, PLASTIC None 8 NDC:11429-1003-2 355 mL in 1 BOTTLE None

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	Operations
Woodbine Products Company		004220323	manufacture (11429-1003)

Revised: 06/2022 Woodbine Products Company