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Dr Sheffield Muscle Rub Cream by Faria LLC dba Sheffield Pharmaceuticals

Dosage form: cream
Ingredients: MENTHOL 100mg in 1g, METHYL SALICYLATE 150mg in 1g
Labeler: Faria LLC dba Sheffield Pharmaceuticals
NDC Code: 11527-057

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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.

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 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)

DR SHEFFIELD MUSCLE RUB CREAM 
muscle rub cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-057
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL100 mg  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 
CETYL ALCOHOL 
TROLAMINE 
WATER 
STEARIC ACID 
OLETH-3 PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:11527-057-401 TUBE in 1 CARTON
135 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/24/2002
Labeler - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Registrant - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797manufacture(11527-057)

Revised: 07/2013
 
Faria LLC dba Sheffield Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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