Label: TRIUMPH DAILY MD- camphor 3% menthol 15% spray

  • 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 February 17, 2020

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

  • ACTIVE INGREDIENT

    Active ingredients                                  Purpose
    dl-Camphor 3% .......................................   Topical analgesic
    dL-Menthol 15% ......................................... Topical analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves aches and pains of muscles and joints associated with one or more of the following:simple backache, lumbago, strains and sprains (involving muscles, tendons and /or ligaments) and arthritis.

    Not recommended for emotional pain. Consult a healthcare practitioner / health care provider / health care professional / doctor / physician for use beyond 7 days.

  • WARNINGS

    Warnings
    For external use only
    • Avoid contact with the eyes and mucous membranes. Do ont use otherwise than as directed.

    Caution: Discontinue use if excessive irritation of the skin develops.

    When using this product

    Do not apply to wounds or damaged skin.

    Do not tightly bandage.

    Do not apply with external heat, such as electric heating pad, as this may result in excessive skin irritation or skin burn.

    Do not inhale.

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if • Hypersensitivity  / allergy, rashes and or burning discomfort occur. • You experience pain, swelling or blistering. •Symptoms worsens •Symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children.

    Seek immediate medical help or contact a Poison Control Center immediately if overdose or accidental ingestion occurs.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older: 1 Spray 3-4 times per day. Apply thinly and evenly to affected area. Rub and / or massage into skin until solution vannishes.

    Children under 12 years of age: Consult a doctor.

  • Other information

    • Store in airtight, light-resistant container at room temperature.
  • Inactive ingredients

    beta-Alanine, Magnesium chloride, SDAG-3, Salix Nigra (Willow) Bark Extract, Aqua (Water), Glycerin, Potassium chloride.

  • Product Label

    image

  • INGREDIENTS AND APPEARANCE
    TRIUMPH DAILY MD 
    camphor 3% menthol 15% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73646-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 mL
    RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860) RACEMENTHOL150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WILLOW BARK (UNII: S883J9JDYX)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .BETA.-ALANINE (UNII: 11P2JDE17B)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73646-001-01120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/20/2020
    Labeler - Dolotech inc. (204095785)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Pharma Inc.200161730manufacture(73646-001)