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  5. Label Information: Dr Sheffield Muscle Rub Cream

FDA Label for Dr Sheffield Muscle Rub Cream

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRINCIPAL DISPLAY PANEL - 1.25 OZ CARTON
    9. PRINCIPAL DISPLAY PANEL -  1.25 OZ TUBE

Dr Sheffield Muscle Rub Cream 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.

Active Ingredients



Menthol - 10%

Methyl salicylate - 15%


Purpose



Topical Analgesic

Topical Analgesic


Uses



  • For temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, bruises and sprains

Warnings



For external use only

Avoid contact with eyes and mucous membranes

  • If conditions worsens, or if symtoms 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 apply 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.


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.
  • Unless treating hands, wash hands throughly wit hsoap and waterimmediately after use.

Other Information



  • Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
  • Close cap tightly afteruse.

Inactive Ingredients



Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Stearic acid, Triethanolamine, Purified Water


Principal Display Panel - 1.25 Oz Carton



Dr. Sheffield's                                     NDC 11527- 057-40

Sheaf-field Trade Mark

MUSCLE RUB Cream

Topical Analgesic

Net WT. 1.25 oz ( 35g)


Principal Display Panel -  1.25 Oz Tube



Dr. Sheffield's                                          NDC 11517-057-40

Sheaf-field Trade Mark

MUSCLE RUB Cream

Topical Analgesic

Net WT. 1.25 oz ( 35g)


* Please review the disclaimer below.