Label: NEEM HAND SANITIZER- hand sanitizer spray

  • NDC Code(s): 81587-622-02
  • Packager: Maharishi Ayur-Ved Products International Corporation
  • 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 January 12, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient Ethyl Alcohol 62% v/v.

  • PURPOSE

    Purpose Antiseptic

  • INDICATIONS & USAGE

    Uses: Hand sanitizer to help reduce germs that potentially can cause disease. Recommended for repeated use.

  • WARNINGS

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

  • DO NOT USE

    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.

  • ASK DOCTOR

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions Spray enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 to avoid swallowing.

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aqua (purified water), Organic glycerin (vegetable), Aloe barbadensis (aloe vera) leaf juice, Herb blend [Curcuma zedoaria (white turmeric) rhizome extract, Azadirachta indica (neem) leaf extract], Menthol, Mentha piperita (peppermint) oil.

  • NEEM HAND SANITIZER

    2oz labelNDC 81587-622-02

  • INGREDIENTS AND APPEARANCE
    NEEM HAND SANITIZER 
    hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81587-622
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CURCUMA ZEDOARIA ROOT (UNII: 123C43G128)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81587-622-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2021
    Labeler - Maharishi Ayur-Ved Products International Corporation (024177843)
    Registrant - Maharishi Ayur-Ved Products International Corporation (024177843)
    Establishment
    NameAddressID/FEIBusiness Operations
    Royal Labs Natural Cosmetics, Inc.197478480manufacture(81587-622)
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