Label: CANYON DIABLO SPIRITS HAND SANITIZER- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated May 22, 2020

If you are a consumer or patient please visit this version.

  • 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

    • in children less than 2 months of age
    • on open skin wounds

    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

    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

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

    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

  • INGREDIENTS AND APPEARANCE
    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)