CANYON DIABLO SPIRITS HAND SANITIZER- alcohol liquid

Drug Details [pdf]

SPL Unclassified
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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 World Health Organization (WHO) recommendations:
1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the

product.
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antisepc
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. Flammabl2. 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 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

Stop use
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.
Other information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients

glycerin, hydrogen peroxide, purified water USP
Directions

Directions
Package Label - Principal Display Panel and Front Label

(Canyon Diablo Spirits logo)

HAND SANITIZER

Alcohol Antiseptic 80%

Topical Solution

Non-sterile Solution

NET 3785 ML (128 FL OZ)

CANYON DIABLO SPIRITS HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74396-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)	18.425 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 74396-001-01	3785 mL in 1 JUG; Type 0: Not a Combination Product	04/01/2020
2	NDC: 74396-001-02	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
3	NDC: 74396-001-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
4	NDC: 74396-001-05	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
5	NDC: 74396-001-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020
6	NDC: 74396-001-07	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020
7	NDC: 74396-001-08	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/01/2020

Labeler - Canyon Diablo Spirits, LLC (025915991)

Name	Address	ID/FEI	Business Operations
Establishment
Canyon Diablo Spirits, LLC		025915991	manufacture(74396-001)

CANYON DIABLO SPIRITS HAND SANITIZER- alcohol liquid

Canyon Diablo Spirits Hand Sanitizer by

Drug Labeling and Warnings

Drug Details [pdf]