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 - 1 Gallon

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
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA CORDIFOLIA FLOWER (UNII: JCG1OSZ7A8)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51452-001-283800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/24/201002/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/24/201002/01/2021
Labeler - Fabrication Enterprises (070577218)
Registrant - Fabrication Enterprises (070577218)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(51452-001)

Revised: 4/2019
 
Fabrication Enterprises