Label: DEAD LIGHTNING - 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 21, 2020

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  • Active Ingredients & Back Label

    picActive ingredient[s]
    Alcohol 80% v/v .................Antiseptic

  • Purpose Section

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

  • Indications and usage section

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

  • Warnings section

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

  • Do not use section

    Do not use
    - in children less than 2 months of age
    - on open skin wounds

  • When using section

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use section

    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 section

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

  • Directions 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 and Administration

    Place enough product on hands to cover all surfaces. (Approx. 1/2 oz.) Rub hands together until dry.

  • Other safety information

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

  • Inactive ingredients section

    Inactive ingredients glycerin, hydrogen peroxide, purified water USP

  • Date of Production & Batch Number

    Date of Production

    Batch Number

  • Principal display panel & front label

    PicDead Lightning Logo


    HAND SANITIZER
    Alcohol Antiseptic 80%
    Topical Solution
    WHO Recommended Hand Rub
    Formulation #1
    FOR EXTERNAL USE ONLY
    NOT SAFE FOR CONSUMPTION
    NON-STERILE SOLUTION
    NET WT.: 5 Gallons (18,926.06 ML)
    Dead Lightning Distillery, LLC
    233 Plum Street, Lemoyne, PA 17043
    Made in USA

  • INGREDIENTS AND APPEARANCE
    DEAD LIGHTNING - HAND SANITIZER 
    dead lightning - hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75451-001
    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
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.23 mL  in 177 mL
    WATER (UNII: 059QF0KO0R) 32.6 mL  in 177 mL
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 2.57 mL  in 177 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75451-001-0118927.06 mL in 1 PAIL; Type 0: Not a Combination Product03/25/2020
    2NDC:75451-001-027570.82 mL in 1 PAIL; Type 0: Not a Combination Product03/25/2020
    3NDC:75451-001-037570.82 mL in 1 JUG; Type 0: Not a Combination Product03/25/2020
    4NDC:75451-001-04709.76 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/25/2020
    5NDC:75451-001-05739.34 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/25/2020
    6NDC:75451-001-06177.44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/2020
    7NDC:75451-001-07236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/25/2020
    Labeler - Dead Lightning Distillery, llc (928310072)
    Registrant - Dead Lightning Distillery, llc (928310072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dead Lightning Distillery, LLC928310072manufacture(75451-001)
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