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  5. Label Information: Sheffield Arthritis And Muscle Pain Relief

FDA Label for Sheffield Arthritis And Muscle Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
    7. DIRECTIONS
    8. INACTIVE INGREDIENTS
    9. OTHER INFORMATION
    10. PRINCIPAL DISPLAY PANEL – 60GM CARTON LABEL
    11. PRINCIPAL DISPLAY PANEL – 60G TUBE LABEL

Sheffield Arthritis And Muscle Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Sheffield Pharmaceuticals 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.

Other



Drug Facts


Active Ingredient



Capsicum Oleoresin 0.075%


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

Avoid contact with the eyes and mucous membranes

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.
  • Discontinue use if excessive irritation of skin develops.
  • If pregnant or breast feeding, ask a health professional before use.
  • A temporary burning sensation may occur upon application, but generally disappears in a few days


Keep This And All Drugs Out Of The Reach Of Children.



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


Directions




  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Unless treating hands, wash thoroughly with soap and water immediately after use.

Inactive Ingredients



Benzyl Alcohol, Cetyl Alcohol, Glyceryl Sterate, Isopropyl Myristate, Paraffin, PEG-100 Stearate, Petrolatum, Purified Water , Sorbitol


Other Information



  • Store at controlled room temperature 20°- 25°C (68° - 77°F)
  • Close the cap tightly after use

Principal Display Panel – 60Gm Carton Label



Sheffield Pharmaceuticals                   NDC 11527-080-60

High Potency 

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

0.075% Capsaicin Topical Analgesic Cream 

NET WT. 60g (2.11oz)


Principal Display Panel – 60G Tube Label



Sheffield Pharmaceuticals          NDC 11527-080-60

High Potency 

ARTHRITIS & MUSCLE PAIN RELIEF CREAM

0.075% Capsaicin Topical Analgesic Cream 

NET WT. 60g (2.11oz)


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