ARTHRITIS RELIEF- menthol, histamine dihydrochloride cream 
Pure Source, LLC

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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)

ArthritisReliefCream

ARTHRITIS RELIEF 
menthol, histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
LICORICE (UNII: 61ZBX54883)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITOL (UNII: 506T60A25R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65121-121-4356.7 g in 1 JAR; Type 0: Not a Combination Product02/09/201709/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/25/201309/28/2023
Labeler - Pure Source, LLC (080354456)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(65121-121)

Revised: 10/2023
 
Pure Source, LLC