COLD SPOT POINT RELIEF- menthol, methyl salicylate 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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Cold Spot Point Relief Pain relieving Gel - 4 oz.

Active Ingredients: Menthol, methyl salicylate

Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.

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.

ColdSpot Point Relief Pain Relieving spray, all natural ingredients.
carton image
COLD SPOT  POINT RELIEF
menthol, methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14 mL  in 120 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE5 mL  in 120 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA CORDIFOLIA FLOWER (UNII: JCG1OSZ7A8)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
CARBOMER 1342 (UNII: 809Y72KV36)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51452-001-04120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/24/2010
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: 2c011b95-a625-49a4-9e9f-d5d8bc58fccc
Set id: 7013706a-3afe-430f-a510-c7735a922150
Version: 3
Effective Time: 20101005
 
Fabrication Enterprises