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

GALLON
(click image for full-size original)

236.59 mL 74105-900-08

8OZ
(click image for full-size original)

3OZ
(click image for full-size original)

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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.