LEVEL 1 HEALTH HAND SANITIZER LIQUID NON-STERILE SOLUTION- alcohol hand sanitizer liquid
Continental Manufacturing Chemist, Inc.

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.

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Drug Facts

Active Ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

in children less than 2 months of age
on open skin wounds

When using this product

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

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Direction

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15 o-30 o C (59 o 86 oF)
Avoid freezing and excessive heat above 40 oC (104 oF)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Principal Display Panel

Level 1 Health

Hand Sanitizer

Liquid

Non-Sterile Solution

Topical Solution

80% Alcohol Antiseptic

XX fl oz (X mL)

Manufactured by

Continental Manufacturing Chemist, Inc.

1501 Blue Sky Blvd, Huxley, IA 50124

www.cmchemist.com

515.795.2000

Made in USA

UPC Code

49794-001-01_32 oz bottle label

LEVEL 1 HEALTH HAND SANITIZER LIQUID NON-STERILE SOLUTION
alcohol hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49794-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
WATER (UNII: 059QF0KO0R)	100 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49794-001-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/08/2020	05/13/2020

Labeler - Continental Manufacturing Chemist, Inc. (005278007)

Name	Address	ID/FEI	Business Operations
Establishment
Continental Manufacturing Chemist, Inc.		005278007	repack(49794-001) , manufacture(49794-001)

Name	Address	ID/FEI	Business Operations
Establishment
Continental Manufacturing Chemist		081171390	manufacture(49794-001) , repack(49794-001)

Revised: 5/2020

Document Id: a59c94f5-b09c-7603-e053-2a95a90aef21

Set id: a2ce1165-144c-e034-e053-2995a90af571

Version: 2

Effective Time: 20200514

Continental Manufacturing Chemist, Inc.