MEDICAL SANITIZER- alcohol gel

Medical Sanitizer by

Drug Labeling and Warnings

Medical Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cedar Medical Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient(s)

Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

Health care personnel hand rub to help reduce bacteria that potentially can cause disease

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

On children less than 2 months of age

On open skin wound

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation occurs. These may be signs of a serious disease.

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

Directions

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

Supervise children under 6 years of age when using the product to avoid swallowing

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Inactive ingredients fragrance, glycerin, *hydroxypropyl cellulose, *hydroxypropyl methylcellulose, water

*May or may not include

SPL UNCLASSIFIED SECTION

UNSCENTED HAND GEL

KILLS 99.9% OF GERMS

WHO FORMULA

MADE IN THE USA

EPA APPROVED FACILITY

Distributed By:

Cedar Medical LLC

Tampa, FL, USA

Packaging

INGREDIENTS AND APPEARANCE

MEDICAL SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80101-102
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
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80101-102-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020
2	NDC: 80101-102-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020
3	NDC: 80101-102-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020
4	NDC: 80101-102-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020
5	NDC: 80101-102-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020
6	NDC: 80101-102-10	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/18/2020

Labeler - Cedar Medical Llc (117581534)