Label: NUMOTIZINE- menthol ointment

  • NDC Code(s): 10546-100-08, 10546-100-35
  • Packager: Hobart Laboratories, Inc.
  • 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 September 16, 2019

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  • NUMOTIZINE OINTMENT


  • Active Ingredients

    Menthol 1.25%

  • Purpose

    Topical Analgesic

  • Inactive ingredients

    Clay, Color, Fragrance of Guaiacol, Methyl Guaiacol and Oil of Wintergreen, Polyols.

  • Directions

    Stir in any liquid at top of jar. Keep sealed when not in use.

    Spread 1/8" to 1/4" of ointment to the skin. Cover the ointment with a cloth or bandage to protect clothing. Remove with warm water before totally dry (usually 8 to 12 hours). Application may be repeated every 12 hours as needed.

  • Uses

    For use as a topical analgesic

    • Provides temporary relief of muscle pain, soreness and stiffness
    • Temporary pain relief on strains, sprains, ligament and tendon injuries
    • Arthritis
  • Stop use and ask a doctor if

    • Excessive irritation of the skin occurs.
    • Persistent swellings.
  • Keep out of the reach of children


  • Warnings:

    For external use only.

    Use only as directed. Avoid contact with eyes and mucous memebranes.

    Do not apply to irritated or broken skin or to large areas of the body.

  • Representative Labeling For - Numotizine Ointment 3.5oz/99g (10546-100-35) | Numotizine Ointment 8oz/228g (10546-100-08)


    Numotizine8


    NumotizineCarton


    NumotizineCartonA


  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    NUMOTIZINE  
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10546-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    GUAIACOL (UNII: 6JKA7MAH9C)  
    CREOSOL (UNII: W9GW1KZG6N)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10546-100-3599 g in 1 JAR; Type 0: Not a Combination Product11/30/2011
    2NDC:10546-100-08228 g in 1 JAR; Type 0: Not a Combination Product11/30/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/30/2011
    Labeler - Hobart Laboratories, Inc. (005111786)
    Registrant - Hobart Laboratories, Inc. (005111786)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hobart Laboratories, Inc.005111786manufacture(10546-100)
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