OTC Medication Information: Hand Sanitizer

HAND SANITIZER- alcohol liquid
Deviation Distilling LLC

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.

ALCOHOL 80% V/V. PURPOSE: ANTISEPTIC

ANTISEPTIC

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry.

Warnings: For external use only. Flammable. Kepp away from heat or flame.

Inactive Ingredients: glycerin, hydrogen peroxide, purified water USP

Use(s): Hand santitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

3785mL 74105-900-01

Hand Sanitizer Gallon.jpg

236.59 mL 74105-900-08

NDC: 74105-900-03

IMAGE: 3oz bottle label.jpg

HAND SANITIZER isopropyl alcohol liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74105-900 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 80 mL

Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE 0.125 mL in 80 mL GLYCERIN 1.45 mL in 80 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:74105-900-01 3785 mL in 1 BOTTLE None 2 NDC:74105-900-08 236.59 mL in 1 BOTTLE, SPRAY None 3 NDC:74105-900-03 88.72 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/27/2020

Labeler — Deviation Distilling LLC (087812644)

Establishment
Name	Address	ID/FEI	Operations
Deviation Distilling LLC		087812644	manufacture (74105-900)

Revised: 03/2020 Deviation Distilling LLC