1. Home
  2. Labeler Index
  3. Pt Elite Products Llc
  4. 85808-615
  5. Label Information: Pt Elite Premium Pain Relief

FDA Label for Pt Elite Premium Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. IF PREGNANT OR BREAST-FEEDING,
    11. DIRECTIONS
    12. OTHER INFORMATION:
    13. INACTIVE INGREDIENTS
    14. STORAGE
    15. QUESTIONS OR COMMENTS
    16. PACKAGE LABELING:

Pt Elite Premium Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Pt Elite Products 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.

Drug Facts




Active Ingredients



Capsaicin 0.035%
Menthol 4.000 %


Purpose



Topical Analgesic


Uses



  • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings



For external use only


Do Not Use



  • on damaged or broken skin.

When Using This Product



  • Avoid contact with the eyes. 
  • Do not bandage tightly.

Stop Use And Ask A Doctor If



  • rash or irritation develops and lasts. 
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


If Pregnant Or Breast-Feeding,



ask a health professional before use


Directions



  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. 
  • Children under 2 years of age: consult a doctor.

Other Information:



  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients



Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Boswellia Serrata Extract, Butylene Glycol, Caprylic/Capric Triglyceride, Ceteareth-20, Cetyl Alcohol, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate SE, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ilex Paraguariensis Leaf Extract, Mineral Oil (Paraffinum Liquidum), Phenoxyethanol, Polysorbate 20, Polysorbate 60, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Squalane, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water (Aqua)


Storage



For best results, store at 68-77F (20-25 C) in dry place.


Questions Or Comments



702-665-4054


* Please review the disclaimer below.