LEVEL1 HEALTH HAND SANITIZER- alcohol antiseptic gel

Level1 Health Hand Sanitizer by

Drug Labeling and Warnings

Level1 Health Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Level 1 Health LLC, Continental Manufacturing Chemist, Inc., Continental Manufacturing Chemist. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

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

STOP USE

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

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

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

INGREDIENTS AND APPEARANCE

LEVEL1 HEALTH HAND SANITIZER 
alcohol antiseptic gel

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74936-001-32	946.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2020

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

Labeler - Level 1 Health LLC (117476751)

Registrant - Level 1 Health LLC (117476751)

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

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