FDA Label for Cold Zone Pain Relieving Gel- Dg Health

View Indications, Usage & Precautions

Cold Zone Pain Relieving Gel- Dg Health Product Label

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

Active Ingredients




Menthol USP 4%


Purpose



Cooling Pain Relief


Uses



Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis - backache - strains - sprains


Warnings:



For external use only


Flammable:



Keep away from excessive heat or open flame.


Ask A Doctor Before Use If You Have:



sensitive skin


When Using This Product:




  • Avoid contact with the eyes or mucous membranes
  • 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 irritated develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device

Stop Use And Ask A Doctor If:



Condition worsens, or if symptoms  persist for more than 7 days, or clear up and recur


If Pregnant Or Breast-Feeding:



Ask a health professional before use


Keep Out Of Reach Of Children:



If accidentally ingested, get medical help or contact a Poison Control Center immediately


Directions:




  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 2 years of age: Consult physician

Other Information:



Store in a cool dry place with lid closed tightly


Inactive Ingredients



Purified water, Glycerin, Isopropyl alcohol, Iso propyl myristate, Carbopol usp, Aloevera gel, Arnica montana flower extract, Articum lappa root (burdock) extract, Boswellia carterii resin extract, Calendula officinalis extract, Camellia sinensis leaf extract, Iiex paraguariensis leaf extract, Melissa officinalis (lemon balm) leaf extract, Tocopheryl acetate, Triethanolamine, Colloidal silicon dioxide, Sorbic acid, Camphor, Brillient blue, Tartrazin supra


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