This is a hand sanitizer manufactured according to the FDA OTC Hand Sanitizer Monograph. The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) and Center for Disease Control (CDC) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin (1.00% v/v).
Hydrogen peroxide (0.125% v/v).
Sterile water or boiled cold water.
Carbomer 940 (<0.5% v/v)
Tea Tree Oil (0.17% v/v)
Lavender Oil (0.17% v/v)
Triethylamine (<0.2% v/v)
Trace amounts of activated charcoal from filtration of the ethanol

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame. Allergy Alert: Contains Tea Tree Oil.

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. 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 10 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, water, activated charcoal, carbomer 940, denatonium benzoate, tea tree oil

Package Label - Principal Display Panel

General Label:

General Label

60 mL OR 2 oz. NDC: 80052-001-01:

2 ounce Label

240 mL OR 8 oz. NDC: 80052-001-02

8 ounce Label

3785 mL OR 128 oz. NDC: 80052-001-03

128 ounce Label

CHIMBORAZO HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80052-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.000005 mL in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.01 mL in 1 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.004 mL in 1 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.0017 mL in 1 mL
TEA TREE OIL (UNII: VIF565UC2G)	0.0017 mL in 1 mL
WATER (UNII: 059QF0KO0R)	0.2742 mL in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.005 mL in 1 mL
TRIETHYLAMINE (UNII: VOU728O6AY)	0.002 mL in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)	0.0001 mL in 1 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80052-001-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/20/2020
2	NDC:80052-001-02	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/20/2020
3	NDC:80052-001-03	3786 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/11/2020

Labeler - Chimborazo LLC (130532330)

Registrant - Chimborazo LLC (130532330)

Name	Address	ID/FEI	Business Operations
Establishment
Chimborazo LLC		130532330	manufacture(80052-001) , label(80052-001)