The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with FDA recommendations: Classification of OTC Consumer Antiseptic Rub Active Ingredients in the 1994 TFM and in the 2016 Proposed Rule. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (60-90%), volume/volume (v/v)) in an aqueous solution denatured

Active Ingredient(s)

Alcohol 75%(Gel) - 80% (Spray) 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 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.

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

glycerin, hydrogen peroxide, purified water USP, Cinnamon Bark Essential Oil

Package Labels - Front and Rear

Essential Oil Sanitizer Spray Cinnamon Bark 4oz

(118 ml /4 fl oz) NDC: 80749-200-10

Essential Oil Hand Sanitizer Cinnamon Bark 1oz

(29.5 ml /1 fl oz.) NDC: 80749-200-20

Essential Oil Hand Sanitizer Cinnamon Bark 16oz

(473ml / 16 fl oz.) NDC: 80749-200-21

Sanitizer Rear Label

rear labels for all sanitizers

CINNAMON BARK SANITIZER
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80749-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	23.66 mL in 29.57 mL

Ingredient Name	Strength
Inactive Ingredients
CINNAMON OIL (UNII: E5GY4I6YCZ)	0.09 mL in 29.57 mL
WATER (UNII: 059QF0KO0R)	5.36 mL in 29.57 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.43 mL in 29.57 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.04 mL in 29.57 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80749-100-10	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/19/2020

CINNAMON BARK HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80749-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	22.2 mL in 29.57 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.04 mL in 29.57 mL
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	0.31 mL in 29.57 mL
CINNAMON OIL (UNII: E5GY4I6YCZ)	0.09 mL in 29.57 mL
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)	0.96 mL in 29.57 mL
WATER (UNII: 059QF0KO0R)	5.4 mL in 29.57 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.4 mL in 29.57 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.15 mL in 29.57 mL

Product Characteristics
Color	white (Mainly Clear Gel)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80749-200-20	29.57 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/19/2020
2	NDC:80749-200-21	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/19/2020

Labeler - Morning Star Aesthetics (117675328)

Registrant - Thomas D Smith (117675328)

Name	Address	ID/FEI	Business Operations
Establishment
Morning Star Aesthetics		117675328	pack(80749-100, 80749-200) , relabel(80749-100, 80749-200) , repack(80749-100, 80749-200) , label(80749-100, 80749-200) , manufacture(80749-100, 80749-200)