Label: HAND SANITIZER- alcohol liquid

  • NDC Code(s): 70722-319-02, 70722-319-04
  • Packager: Little Moon Essentials
  • 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 December 30, 2020

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  • Active Ingredient(s)

    Alcohol 65% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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

    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.

  • STOP USE

    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

    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

    aloe, Chinese cinnamon leaf oil, clove oil, eucalyptus oil, glycerin, lavender oil, lemon oil, orange oil, peppermint oil, rosemary oil, tea tree oil, water

  • Package Label - Principal Display Panel

    60 mL60 mL118 mL NDC: 70722-319-04

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70722-319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LEMON OIL (UNII: I9GRO824LL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE (UNII: V5VD430YW9)  
    CLOVE OIL (UNII: 578389D6D0)  
    CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70722-319-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/20/2020
    2NDC:70722-319-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - Little Moon Essentials (840835115)
    Registrant - Little Moon Essentials LLC (840835115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Little Moon Essentials LLC840835115manufacture(70722-319)
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