Label: ORTHO-NESIC WITH CAPSAICIN- menthol gel

  • NDC Code(s): 63347-401-01, 63347-401-02, 63347-401-03, 63347-401-04
  • Packager: Blaine Labs Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

If you are a consumer or patient please visit this version.

  • 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

    res8.14.20

    blaine_o-n_gel_capsa_6oz

    blaine_o-n_paraben_free_1gal

    blaine_o-n_roll_on_capsa_3oz

    RES

  • INGREDIENTS AND APPEARANCE
    ORTHO-NESIC WITH CAPSAICIN 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-401
    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:63347-401-01170 g in 1 TUBE; Type 0: Not a Combination Product01/01/1995
    2NDC:63347-401-02907 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/1995
    3NDC:63347-401-033629 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/1995
    4NDC:63347-401-0485 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/1995
    Labeler - Blaine Labs Inc. (017314571)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture(63347-401)