Active Ingredient(s)

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

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.

Directions

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 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Purified water USP, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Vitamine E Acetate, Carbomer, Propylene Glycol, Triethanolamine

Package Label - Principal Display Panel

Image of 32 oz label Image of 10 oz label Image of 8.4 oz label

LEVEL 1 HEALTH

Hand Sanitizer

Premium Moisturizing Gel

Unscented

WITH ALOE + VITAMIN E

70% Alcohol Antiseptic

XX FL OZ (XXX.X mL)

MADE IN USA

Distributed by

Level 1 Health

3636 S Geyer Rd. Suite 100

St. Louis, MO 63127

www.level1health.com | (314) 238-7348

LEVEL1 HEALTH HAND SANITIZER
alcohol antiseptic gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74936-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74936-001-32	946.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2020
2	NDC:74936-001-08	249 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2020
3	NDC:74936-001-10	295.7 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/12/2020

Labeler - Level 1 Health LLC (117476751)

Registrant - Level 1 Health LLC (117476751)

Name	Address	ID/FEI	Business Operations
Establishment
Continental Manufacturing Chemist, Inc.		005278007	manufacture(74936-001) , analysis(74936-001) , pack(74936-001) , repack(74936-001) , label(74936-001) , relabel(74936-001)

Name	Address	ID/FEI	Business Operations
Establishment
Continental Manufacturing Chemist		081171390	manufacture(74936-001) , pack(74936-001) , label(74936-001) , repack(74936-001) , relabel(74936-001) , api manufacture(74936-001)

Level 1 Health OTC hand sanitizer