CANYON DIABLO SPIRITS HAND SANITIZER- alcohol liquid 
Canyon Diablo Spirits, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Sanitizer

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.

SPL Unclassified

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antisepc

Active Ingredient(s)

Purpose

Antiseptic, Hand Sanitizer

purpose

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Use(s)

Warnings

For external use only. Flammabl2. Keep away from heat or flame

Warnings

Do not use

Do Not Use

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.

When Using

Stop use

Stop use

Stop Using

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep Out of Reach of Children

Other information

Other Information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Inactive Ingredients

Directions

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)

Front Label

CANYON DIABLO SPIRITS HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74396-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74396-001-013785 mL in 1 JUG; Type 0: Not a Combination Product04/01/2020
2NDC:74396-001-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
3NDC:74396-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
4NDC:74396-001-05236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
5NDC:74396-001-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
6NDC:74396-001-07946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
7NDC:74396-001-081893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
8NDC:74396-001-0918297 mL in 1 CONTAINER; Type 0: Not a Combination Product04/25/2020
9NDC:74396-001-1060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2020
Labeler - Canyon Diablo Spirits, LLC (025915991)
Establishment
NameAddressID/FEIBusiness Operations
Canyon Diablo Spirits, LLC025915991manufacture(74396-001)

Revised: 5/2020
Document Id: a6410853-649d-d7f4-e053-2a95a90a6efd
Set id: a23ea4d3-096c-3c62-e053-2995a90a4697
Version: 7
Effective Time: 20200522
 
Canyon Diablo Spirits, LLC