HOT SPOT POINT RELIEF- capsaicin gel 
fabrication enterprises

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.

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Hot Spot Point Relief Pain relieving gel - 3 oz.

Active Ingredients: Capsaicin

Inactive Ingredients: deionized water, oil of Cassia, chondroitin sulfate, glucosamine sulfate,Glycrrhiza Glabra (licorice) extract, Carbomer, Triethanolamine,  polysorbate-20, Phenoxyethanol, Ethylhexylglycrine.

Keep out of reach of children. If swallowed consult physician

Warnings Section: For external use only, avoid contact with eyes, do not apply to open wounds or damaged skin, if symptoms persist for more than seven days discontinue use and consult physician, keep out of reach of children and if swallowed consult physician, do not bandage tightly.

Pain relieving gel

Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.



 

Apply directly to effected area. Do not use more than four times per day.

HotSpot Point Relief Pain Relieving gel, all natural ingredients.
carton image
HOT SPOT  POINT RELIEF
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.5 mL  in 90 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51452-010-0390 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/24/2010
Labeler - fabrication enterprises (070577218)
Registrant - fabrication enterprises (070577218)
Establishment
NameAddressID/FEIBusiness Operations
fabrication enterprises070577218relabel
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture

Revised: 10/2010
Document Id: 6bc5eb25-fdf2-46e9-b082-e5f513fe4a4c
Set id: 34ad88ef-8c14-44b8-accc-d04f87ad3ca7
Version: 4
Effective Time: 20101005
 
fabrication enterprises