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, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Capsaicin

INACTIVE INGREDIENT

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

Keep out of reach of children. If swallowed consult physician

WARNINGS

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.

PURPOSE

Pain relieving gel

INDICATIONS & USAGE

Use: For temporary 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 effected area. Do not use more than four times per day.

PRINCIPAL DISPLAY PANEL

HotSpot Point Relief Pain Relieving gel, all natural ingredients.

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	1.5 mL  in 240 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: 51452-010-08	240 mL in 1 TUBE

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