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Hot spot point relief by Fabrication Enterprises, inc.

Medically reviewed on October 13, 2017

Dosage form: gel
Ingredients: CAPSAICIN .03mL in 5mL
Labeler: Fabrication Enterprises, inc.
NDC Code: 51452-010

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

acitve ingredients: capsaicin

aqua (deionized water), carbomer, cassia oil, choldroitin sulfate, ethylhexylglycerine, glucosamine sulfate, glycrrhiza glabra (licorice) extract, phenoxyethanol, polysorbate-20

keep out of reach of children. if swallowed consult physician.

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. if swallowed, consult physician.

do not bandage tightly

external analesic

for temprorary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

apply directly to affected area. do not use more than four times per day.

HOT SPOT  POINT RELIEF
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN.03 mL  in 5 mL
Inactive Ingredients
Ingredient NameStrength
water 
polysorbate 20 
CHONDROITIN SULFATE (BOVINE) 
Glucosamine sulfate 
GLYCYRRHIZA GLABRA 
CARBOMER 1342 
PHENOXYETHANOL 
CASSIA FISTULA FRUIT 
ETHYLHEXYLGLYCERIN 
Packaging
#Item CodePackage Description
1NDC:51452-010-005 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34810/13/2011
Labeler - Fabrication Enterprises, inc. (070577218)
Registrant - Pure Source (969241041)
Establishment
NameAddressID/FEIOperations
pure source969241041manufacture

 
Fabrication Enterprises, inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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