ArthriPain Relief

Dosage form: cream
Ingredients: Menthol 12.5mg in 1g
Labeler: NDI Solutions LLC
NDC Code: 50972-278

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.

Drug Facts

Active Ingredient                                                                            Purpose

Menthol 1.25%.................................................................Pain relieving cream

Use  Temporarily relieves minor aches and  pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do not use
  • on wounds or damaged skin

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children

Directions
  • Adult and children 2 years of age and older: Apply to affected area not more than  3 to 4 times daily.
  • Children under 2 years of age: Consult a physician.

Inactive Ingredients: aloe vera gel, cetyl alcohol, cetyl esters
(proprietary blend of esterfied fatty acids)(7.5%), cinnamon oil,
eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba
oil, peppermint oil, potassium sorbate, purified water, squalane, stearic
acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.

ArthriPain packaging

ARTHRIPAIN RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50972-278
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol12.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf 
Cetyl Alcohol 
Cetyl Esters Wax 
Cinnamon Oil 
EUCALYPTUS OIL 
GLYCERYL MONOSTEARATE 
GRAPE SEED OIL 
HYPROMELLOSE 
JOJOBA OIL 
PEPPERMINT OIL 
POTASSIUM SORBATE 
WATER 
SQUALANE 
STEARIC ACID 
STEARYL ALCOHOL 
TEA TREE OIL 
GLYCERIN 
METHYL SALICYLATE 
Packaging
#Item CodePackage Description
1NDC:50972-278-0157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2010
Labeler - NDI Solutions LLC (828825989)

Revised: 04/2010
 
NDI Solutions LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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