Label: CAJUN SPIRITS HAND SANITIZER- ethanol 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 March 27, 2020

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  • Active Ingredients[s].

    Alcohol 80%v/

  • Purpose

    Anticeptic

  • 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. Flammable. Keep away from heat or flame

    Do not 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.

  • 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.

  • Other Information

    • Store between 15-30C (59-86F)

    • Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Hand Sanitizer Labels

    Front Label 32ozFront Label 32ozFront Label 6ozFront Label 1ozBack Label - All versionsFront Label 1/2galFront Label 2ozFront Label 5galFront Label 16oz4oz Front

  • INGREDIENTS AND APPEARANCE
    CAJUN SPIRITS HAND SANITIZER 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74152-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL23.659 mL  in 29.574 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.037 mL  in 29.574 mL
    WATER (UNII: 059QF0KO0R) 5.449 mL  in 29.574 mL
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 0.429 mL  in 29.574 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74152-001-0129.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    2NDC:74152-001-0259.1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    3NDC:74152-001-04118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    4NDC:74152-001-06177.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    5NDC:74152-001-08236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    6NDC:74152-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    7NDC:74152-001-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    8NDC:74152-001-0518927 mL in 1 PAIL; Type 0: Not a Combination Product03/27/2020
    9NDC:74152-001-181893 mL in 1 JUG; Type 0: Not a Combination Product03/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/27/2020
    Labeler - Cajun Spirits Distillery, LLC (002075890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cajun Spirits Distillery, LLC002075890manufacture(74152-001)
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