HOT SPOT POINT RELIEF- capsaicin gel

Hot spot by

Drug Labeling and Warnings

Hot spot by is a Otc medication manufactured, distributed, or labeled by Fabrication Enterprises, inc., Pure Source, pure source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

acitve ingredients: capsaicin

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

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

PURPOSE

external analesic

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOT SPOT  POINT RELIEF
capsaicin gel

Product 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	.03 mL  in 5 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)
CASSIA FISTULA FRUIT (UNII: J65X53KM9E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-010-00	5 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	10/13/2011

Labeler - Fabrication Enterprises, inc. (070577218)

Registrant - Pure Source (969241041)

Establishment
Name	Address	ID/FEI	Business Operations
pure source		969241041	manufacture