Dr Sheffield Muscle Rub Cream
FDA Label NDC 11527-057

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 Dr Sheffield Muscle Rub Cream (NDC 11527-057). 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 active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, principal display panel - 1.25 oz carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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