SHEFFIELD ARTHRITIS AND MUSCLE PAIN RELIEF- capsicum oleoresin cream 
Sheffield Pharmaceuticals LLC

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Sheffield Thermarub Capsaicin Cream 

Drug Facts

Active Ingredient

Capsicum Oleoresin 0.075%

Purpose


<Topical analgesic>

Uses

Warnings


For external use only

Avoid contact with the eyes and mucous membranes

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

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)

Sheffield Pharma 0.075 Capsaicin 60g Carton

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)

Sheffield Pharma  For 0.075 Capsaicin 60g Tube

Sheffield Pharma  For 0.075 Capsaicin 60g Tube

SHEFFIELD ARTHRITIS AND MUSCLE PAIN RELIEF 
capsicum oleoresin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN.075 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-080-601 in 1 CARTON12/22/2020
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/22/2020
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-080) , analysis(11527-080)

Revised: 11/2023
Document Id: 18f1103f-c3e6-4451-bc74-019bb6dc9bfe
Set id: 724b9870-e86a-4087-ba78-8c944ce3baa6
Version: 3
Effective Time: 20231128
 
Sheffield Pharmaceuticals LLC