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  5. Label Information: Muscle Freeze Relief

FDA Label for Muscle Freeze Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER:
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL – 85 G CONTAINER LABEL

Muscle Freeze Relief Product Label

The following document was submitted to the FDA by the labeler of this product Natural Essentials, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



SHAKE WELL

Children under 12 years of age: consult a doctor.


Active Ingredient



Menthol 3.7%


Purpose



Topical Analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings



For external use only.

Flammable: Keep away from fire or flame and heated surfaces


Do Not Use



  • if you are allergic to any ingredient in this product
  • on open wounds, damaged or irriated skin
  • with a heating pad or TENS device
  • after expiration date

When Using This Product



  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes

Stop Use And Ask A Doctor If



  • condition worsens
  • rash, itching, redness or excessive irritation of the skin develops
  • symptoms persist for more than 7 days
  • symptoms dear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.


Adults And Children 12 Years Of Age And Over:



  • apply to affected area no more than 4 times a day
  • massage painful area until absorbed into skin
  • wash hands after each use with cold water

Other Information



  • store in a cool place away from direct sunlight
  • store with cap closed tightly

Inactive Ingredients



Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, Ilex Paraguariensis leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.


Principal Display Panel – 85 G Container Label



Muscle
Freeze
Relief Gel

Net Wt. 3 oz. (85 g)

Principal Display Panel – 85 g Container Label - mus05 0000 01

Principal Display Panel – 85 g Container Label - mus05 0000 01


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