DAKOTA MUSCLE RELIEF ROLL-ON (MENTHOL, UNSPECIFIED FORM) SOLUTION [LASHE NATURALS, LLC]

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DAKOTA MUSCLE RELIEF ROLL-ON (MENTHOL, UNSPECIFIED FORM) SOLUTION [LASHE NATURALS, LLC]
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NDC 71680-002-03
Set ID 880d39d5-63ba-42c2-996a-78b835550524
Category HUMAN OTC DRUG LABEL
Packager LaShe Naturals, LLC
Generic Name
Product Class
Product Number
Application Number PART348
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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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