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Arthritis Relief by Pure Source, LLC

Medically reviewed on February 10, 2017

Dosage form: cream
Ingredients: MENTHOL 3g in 100g, HISTAMINE DIHYDROCHLORIDE 0.025g in 100g
Labeler: Pure Source, LLC
NDC Code: 65121-121

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.

Arthritis Relief Cream

Arthritis Relief Cream


Active Ingredient:

Menthol 3.00%

Histamine Dihydrochloride 0.025%

Purpose

External Analgesic

Uses:

For temporary relief of minor aches and pains associated with simple backache, arthritis, bruises and sprains.

Warnings:
  • 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.

If swallowed, consult physician.

Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Apply directly to affected area. Do not use more than four times per day.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Carbomer, Chondroitin Sulfate, Emu Oil, Ethylhexylglycerin, Glucosamine HCl, Glycerrhiza Glabra (Licorice) Extract, Helianthus Annus (Sunflower) Oil, Lidocaine HCl, Methylsultonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Sorbitol, Triethanolamine

Arthritis Relief Cream 2oz/56.7g (65121-431-21)

ARTHRITIS RELIEF 
menthol, histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-121
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
CHONDROITIN SULFATE (BOVINE) 
EMU OIL 
ETHYLHEXYLGLYCERIN 
GLUCOSAMINE HYDROCHLORIDE 
LICORICE 
SUNFLOWER OIL 
LIDOCAINE HYDROCHLORIDE 
DIMETHYL SULFONE 
PHENOXYETHANOL 
POLYSORBATE 20 
SORBITOL 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:65121-121-4356.7 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/25/2013
Labeler - Pure Source, LLC (080354456)
Establishment
NameAddressID/FEIOperations
Pure Source, LLC080354456manufacture(65121-121)

 
Pure Source, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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