Label: NOVUM APR- menthol spray

  • NDC Code(s): 69574-005-04, 69574-005-05
  • Packager: NOVUM SOLUTIONS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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  • Drug Facts

    Topical Burn Cream Plus Pain Relief

  • Active Ingredient

    Menthol 0.5%

  • Purpose

    Pain & Itch Relief

    For the temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, and sprains.

  • Indications

    For cooling, deep-penetrating pain relief, spray Novum APR generously on the skin around aching joints or muscle pain and allow to dry without rubbing.
    Apply as often as needed.

  • Warnings

    Not intended for use on children under 2 years old except as directed by a doctor.
    Avoid contact with eyes.
    For external use only.
    If irritation develops and persists, discontinue use and consult a doctor.
    If condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

  • ​KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN

    ​KEEP OUT OF REACH OF CHILDREN

  • Directions

    Apply this product topically to affected areas and allow to dry without rubbing.
    Use as often as needed.
    Use only as directed.

  • Other Information

    External analgesic

  • Inactive Ingredients

    ISOPROPYL ALCOHOL, PURIFIED WATER, METHYL SALICYLATE, EUCALYPTUS ESSENTIAL OIL, SPEARMINT ESSENTIAL OIL.

  • Questions or Comments

    ​Novum Solutions, Inc.

    1585 West Sam Houston Pkwy N, #820

    Houston, TX 77403

    www.NovumSolutions.com

    CALL 832-200-8005

    FAX 713-464-6319

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    NOVUM  APR
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69574-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69574-005-051 in 1 BOX05/19/2015
    1NDC:69574-005-04118.3 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/19/2015
    Labeler - NOVUM SOLUTIONS INC (044818941)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(69574-005)
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