NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]

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NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]
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NDC 10546-100-08, 10546-100-35
Set ID 9a29ad1b-4ba3-403f-90c9-ee7582fe4535
Category HUMAN OTC DRUG LABEL
Packager Hobart Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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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