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Hot Spot Point Relief by Pure Source

Dosage form: gel
Ingredients: CAPSAICIN 0.5mL in 90mL
Labeler: Pure Source
NDC Code: 65121-010

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.

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.

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

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.
HOT SPOT  POINT RELIEF
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.5 mL  in 90 mL
Inactive Ingredients
Ingredient NameStrength
water 
polysorbate 20 
CHONDROITIN SULFATE (BOVINE) 
Glucosamine sulfate 
GLYCYRRHIZA GLABRA 
CARBOMER 1342 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:65121-010-0390 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/24/2010
Labeler - Pure Source (969241041)
Registrant - Pure Source (969241041)
Establishment
NameAddressID/FEIOperations
Pure Source969241041manufacture

Revised: 08/2010
 
Pure Source

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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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