MEDICAL SANITIZER- alcohol gel 
Cedar Medical 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.

----------

Medical© SANITIZER

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

*May or may not include

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

IMAGE

IMAGE

IMAGE

IMAGE

IMAGE

IMAGE

MEDICAL SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80101-102
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
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80101-102-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
2NDC:80101-102-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
3NDC:80101-102-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
4NDC:80101-102-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
5NDC:80101-102-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
6NDC:80101-102-103780 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/18/2020
Labeler - Cedar Medical Llc (117581534)

Revised: 8/2020
Document Id: 1e66bd8c-2582-400a-98eb-31b92e68a5ef
Set id: aa700141-a367-4b2d-84a9-753600ff197f
Version: 1
Effective Time: 20200818
 
Cedar Medical Llc