Label: HOT SPOT POINT RELIEF- capsaicin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51452-010-32 - Packager: fabrication enterprises
- Category: HUMAN OTC DRUG LABEL
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 October 5, 2010
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INGREDIENTS AND APPEARANCE
HOT SPOT POINT RELIEF
capsaicin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51452-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 5.8 mL in 960 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) polysorbate 20 (UNII: 7T1F30V5YH) CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) Glucosamine sulfate (UNII: 1FW7WLR731) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CARBOMER 1342 (UNII: 809Y72KV36) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51452-010-32 960 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/24/2010 Labeler - fabrication enterprises (070577218) Registrant - fabrication enterprises (070577218) Establishment Name Address ID/FEI Business Operations fabrication enterprises 070577218 relabel Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture