Dakota Muscle Relief: Package Insert and Label Information

DAKOTA MUSCLE RELIEF- menthol, unspecified form spray
LaShe Naturals, LLC

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 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

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

PRINCIPAL DISPLAY PANEL — 240 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

Spray-On Muscle Relief
8oz. (240ml.)

Principal Display Panel -- 240 ml Bottle Label
(click image for full-size original)
DAKOTA MUSCLE RELIEF
menthol, unspecified form spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71680-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL
Water
Peppermint Oil
Eucalyptus Oil
Camphor Oil, White
CLOVE OIL
Emu Oil
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71680-001-08 240 mL in 1 BOTTLE, PLASTIC None
2 NDC:71680-001-02 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 07/01/2008
Labeler — LaShe Naturals, LLC (053397499)

Revised: 12/2021 LaShe Naturals, LLC

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