COLD SPOT POINT RELIEF- menthol aerosol, spray 
Pure Source

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.

----------

Cold Spot Point Relief Pain relieving Spray - 2 oz. Spray

Active Ingredients: Menthol

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.

Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

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.
image of carton label
COLD SPOT  POINT RELIEF
menthol aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol6 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
ARNICA CORDIFOLIA FLOWER (UNII: JCG1OSZ7A8)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
Citric Acid (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:65121-003-0260 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/24/2010
Labeler - Pure Source (969241041)
Registrant - Pure Source (969241041)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture

Revised: 9/2010
Document Id: aef8b744-b314-49c0-a222-973a40037471
Set id: ae5fc436-9a8b-44e3-8b7d-94fb5a80c084
Version: 5
Effective Time: 20100909
 
Pure Source