Sheffield Arthritis And Muscle Pain Relief Cream
FDA Label NDC 11527-080

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Sheffield Arthritis And Muscle Pain Relief (NDC 11527-080). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, keep this and all drugs out of the reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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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