Label: TRAUMA LESS- menthol ointment

  • NDC Code(s): 69204-010-01, 69204-010-02
  • Packager: Natures Formulae Health Products Ltd.
  • 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 October 13, 2018

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  • SPL UNCLASSIFIED SECTION

    IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION.

  • DRUG FACTS Active ingredient

    Menthol 1.27%

  • PURPOSE

    Purpose Topical Analgesic

    Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

  • Warnings

    For external use only.

    Flammable: Keep away from fire or flame.

  • Do not use

    • on wounds or damaged skin
    • if allergic to plants of the asteraceae/compositae/daisy family.
  • When using this product

    • avoid contact with the eyes
    • do not bandage tightly
  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. 

  • If pregnant or breast-feeding,

    ask a doctor before use.

  • Keep out of reach of children. 

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to affected area 
  • DOSAGE & ADMINISTRATION

          not more than 3 times daily.

    • Not recommended for children under 12 years of age.
  • Inactive ingredients

    Arnica montana flower extract, beeswax (yellow), olive oil, and peppermint oil.

  • Questions?

    1-877-275-7253

  • SPL UNCLASSIFIED SECTION

    Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada

    DO NOT USE IF SECURITY SEAL AROUND TIN IS BROKEN OR MISSING.

    SKU 435301

    Lift Here

  • DISPOSAL AND WASTE HANDLING

    We support recycling.  Please recycle where possible. 

  • Trauma Less Topical Analgesic Ointment

    Saje® Natural Wellness

    Trauma Less

    Topical Analgesic Ointment

    net wt. 1.91 oz | 54.1 g and net wt. 0.47 oz | 13.5 g Trauma less 13.5 g

    Trauma Less 54.1 g BOX

  • INGREDIENTS AND APPEARANCE
    TRAUMA LESS 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69204-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69204-010-011 in 1 BOX10/16/2016
    154.1 g in 1 CANISTER; Type 0: Not a Combination Product
    2NDC:69204-010-0213.5 g in 1 CANISTER; Type 0: Not a Combination Product10/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/16/2016
    Labeler - Natures Formulae Health Products Ltd. (241385587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(69204-010)
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