ARTHRITIS RELIEF- menthol, histamine dihydrochloride cream

Arthritis Relief by

Drug Labeling and Warnings

Arthritis Relief by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ARTHRITIS RELIEF 
menthol, histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-121-43	56.7 g in 1 JAR; Type 0: Not a Combination Product	02/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/25/2013

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-121)