Label: ORTHO-NESIC WITH CAPSAICIN- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 25, 2011

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  • Active Ingredients

    Camphor - 0.2%

    Menthol - 3/5%

  • Inactive Ingredients

    Water, SDA Alcohol 40-B, Carbomer, Isopropyl Alcohol, Ilex Paraguariensis Leaf Extract, Camelia Sinensis (Green Tea) Leaf Powder, FD and C Blue #1, FD and C Yellow #5, Triethanolamine

  • Purpose

    Topical Analgesic

  • Uses

    For temporary relief from minor aches and pains of sore muscles and joints associated with arthritis pain, backache, strains and sprains

    Directions: Apply to the affected areas not more than 3 to 4 times daily.  Rinse hands with cool water.

  • Ask Your Physician

    Ask Your Physician

    Before use if you are pregnant, nursing or have sensitive skin

    Before use on children under the age of 2 years old

    Keep Out Of The Reach Of Children

    Stop Use and Contact Your Physician if conditions worsen or if symptoms persist for more than 7 days, or clear up and recur again within a few days.

  • When Using This Product

    Avoid contact with the eyes or mucous membranes.  In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

  • Other Information

    Store in a cool dry place with lid closed tightly.  Keep away from excessive heat or open flame

  • Warnings

    Use only as directed.  For external use only.  Do not use with other sprays or ointments creams or liniments.  Do not apply to irritated skin or if excessive irritation develops.  Do Not bandage.  Do not sue with heating pads or devices.

  • Ortho-Nesic Label

    Ortho-Nesic Pain Relieving Gel  Penetrates Fast and Deep  Relieves Sore Muscles and Joints

    Physician Formula  Greaseless, Stainless  Great for Arthritis and Sports Injuries  Stops the Pain.  With Capsaicin, Ilex and Green Tea. Paraben Free

    3 Ounce Tube Label

    6 Ounce Tube Label

    1 Gallon Label





  • INGREDIENTS AND APPEARANCE
    ORTHO-NESIC WITH CAPSAICIN 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65373-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65373-401-01170 g in 1 TUBE
    2NDC:65373-401-02907 g in 1 BOTTLE, PUMP
    3NDC:65373-401-033629 g in 1 BOTTLE, PUMP
    4NDC:65373-401-0485 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1995
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture
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