Label: SHEFFIELD ARTHRITIS AND MUSCLE PAIN RELIEF- capsicum oleoresin cream
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- NDC Code(s): 11527-080-60
- Packager: Sheffield Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated August 21, 2020
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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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
- Inactive ingredients
- Other Information
- Principal Display Panel – 60gm Carton Label
- Principal Display Panel – 60g Tube Label
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INGREDIENTS AND APPEARANCE
SHEFFIELD ARTHRITIS AND MUSCLE PAIN RELIEF
capsicum oleoresin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN .075 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-080-60 1 in 1 CARTON 12/22/2020 1 60 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/22/2020 Labeler - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(11527-080)
