Label: BLACK DIAMOND DISTILLERY HAND SANITIZER 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 April 7, 2020

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

  • Active ingredients & back label

    Active ingredient(s)

    Alcohol 80% v/v.......Antiseptic Active ingredients

  • Do not use

    Do not use

    • in children less than 2 months of age
    • on open skin wounds
      Do not 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. Keep out of reach of children

  • Purpose

    Use(s)

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

  • Stop Use

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Stop 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. When using

  • Other safety information

    Other information

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

    Warnings

    For external use only Flammable. Keep away from heat or flame. Warnings and Precautions

  • Instructions for use

    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.
      Instruction for Use
  • Inactive ingredient

    Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP Inactive ingredients

  • Dosage and administration section

    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.
      Dosage
  • Warnings

    Warnings

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

    Do no 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.

    Warnings

  • Indications & Usage Section

    Use(s)

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

    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.
      Uses(s)
  • Package label principal display panel

    New Straitsville

    (Black Diamond Distillery logo image)

    Black Diamond

    Distillery

    Hand Sanitizer

    Alcohol Antiseptic 80%

    Topical Solution

    WHO Recommended Antiseptic Hand Rub

    Formulation #1

    FOR EXTERNAL USE ONLY

    NOT SAFE FOR CONSUMPTION

    NON-STERILE SOLUTION

    NET WT: 1 GAL. (3785.41mL)

    Black Diamond Distillery

    105 W. Main Street, P.O. Box 495

    New Straitsville, Ohio 43766

    Made in USA

    (Hocking College Logo image)

    DATE:_______BATCH:_______

    EXPIRES 30 DAYS FROM DATE ABOVE Package label principal display panel

  • INGREDIENTS AND APPEARANCE
    BLACK DIAMOND DISTILLERY HAND SANITIZER 
    black diamond distillery hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74815-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL141.6 mL  in 177 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 2.57 mL  in 177 mL
    WATER (UNII: 059QF0KO0R) 32.6 mL  in 177 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.23 mL  in 177 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74815-0001-13785.41 mL in 1 JUG; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2020
    Labeler - Hocking Technical College (071648950)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hocking Technical College071648950manufacture(74815-0001)