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  5. Label Information: Therafreeze

FDA Label for Therafreeze

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. WHEN USING THIS PRODUCT:
    7. STOP USE AND ASK DOCTOR IF
    8. IF PREGNANT OR BREASTFEEDING:
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS:
    13. PRINCIPAL DISPLAY PANEL

Therafreeze Product Label

The following document was submitted to the FDA by the labeler of this product Astrum Pharma. 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



Drug Facts

For more information,
please visit our website
www.astrumpharma.com

Manufactured in the USA

No Animal Testing

Distributed and Marketed by:
Astrum Pharma, Jersey City,
NJ-07307


Active Ingredients



Menthol USP 6%


Purpose



Pain Reliever


Uses



Temporary relief from minor aches and pains from sore muscles & joints associated with arthritis, backache, strains and sprains.


Warnings



For external use only.

Flammable: Keep away from excessive heat or open flame.

Ask a doctor before use if you have: sesnitive skin.


When Using This Product:



  • Avoid contact with eyes or mucous membrane.
  • Do not apply to wounds or damaged skin.
  • Do not use with other ointments, creams, sprays or liniments.
  • Do not apply to irritated skin or if excessive irritation develops.
  • Do not bandage tightely.
  • Wash hands after use with cold water.
  • Do not use with a heating pad or device.

Stop Use And Ask Doctor If



  • conditions worsen.
  • symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.

If Pregnant Or Breastfeeding:



Ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children:If accidently ingested, get medical help or contact a Poison Control Center immediately.


Directions



Adults and children 12 years of age and older: Apply on the affacted areas not more than 4 times a day.

Children under 2 years of age: Consult physician.


Other Information



Store in cool dry place.


Inactive Ingredients:



Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctum Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, C13-14 Isoparaffin, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer-940, Cetearyl Oliviate, Citrus Media Limonum (Essential Lemon) Oil, Ethylhexylglycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Distillate, Helianthus Annuus (Sunflower) seed Oil, IIex Paraguariensis Leaf (Yerba Mate') Extract, Laureth-7, Methylsulfonylmethane (MSM), PEG - 100 Stearate, Phenoxyethanol, Polyacrylmide, Polysorbate - 20, Propylene Glycol, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin - E), Triethanolamine.


Principal Display Panel



SOOTHING PAIN RELIEF FROM ARTHRITIS, BACK PAIN,
SORE MUSCLES AND JOINTS

Cool Therapy Pain Relieving Gel

THERAFREEZETM

Vanishing Scent •Natural Menthol •Paraben Free

NDC # 57329-010-01

16 FL OZ

473 ML

therafreeze Display - label 1

therafreeze Display - label 1


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