Label: DAKOTA MUSCLE RELIEF ROLL-ON- menthol, unspecified form solution

  • 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 December 8, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Menthol 6.0%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains associated with

    • simple backache
    • arthritis
    • sprains
    • joint pain
    • bruises
    • strains.
  • Warnings

    For external use only. Avoid contact with eyes. If contact occurs, flush eyes with water immediately.

    Flammable

    Keep away from fire or flame.

    When using this product:

    • Use only as directed
    • Do not bandage or use with a heating pad
    • Do not apply to wounds or damaged skin
    • Discontinue use if irritation develops.

    Stop use and ask your doctor if:

    Condition worsens or if symptoms persist more than 7 days

    • redness is present
    • excessive irritation of the skin develops.

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

    Keep out of reach of children, if ingested get medical help immediately.

  • Directions

    Adults / Children 12 years or older:

    • Shake well before use, test for skin sensitivity
    • Spray directly on affected area
    • Apply externally up to a maximum of 3 to 4 times a day
    • Do not rub.
  • Inactive Ingredients

    Clove Bud, Emu Oil, Eucalyptus Oil, Isopropyl Alcohol, Peppermint Oil, Water, White Camphor

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    LaShe Naturals, LLC
    405 West Main, Suite 5D, West Fargo, ND 58078

  • PRINCIPAL DISPLAY PANEL - 90 ml Bottle Label

    Dakota
    MUSCLE RELIEF

    FAST ALL NATURAL PAIN RELIEF

    Temporary Relief From:

    • Arthritis
    • Joint Pain
    • Back Pain
    • Sprains
    • Muscle Aches
    • Cramps
    • Congestion
    • Insect Bites

    FAST ACTING • NOT GREASY
    PLEASANT SCENT

    Roll-On Muscle Relief
    3oz. (90ml.)

    PRINCIPAL DISPLAY PANEL - 90 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    DAKOTA MUSCLE RELIEF ROLL-ON 
    menthol, unspecified form solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71680-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Water (UNII: 059QF0KO0R)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Camphor Oil, White (UNII: 26P3H26Z9X)  
    CLOVE OIL (UNII: 578389D6D0)  
    Emu Oil (UNII: 344821WD61)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71680-002-0390 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34811/01/2011
    Labeler - LaShe Naturals, LLC (053397499)
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