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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65121-121-43	56.7 g in 1 JAR; Type 0: Not a Combination Product	02/09/2017	09/28/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/25/2013	09/28/2023

Labeler - Pure Source, LLC (080354456)

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

Revised: 10/2023

Document Id: 071b9257-9e81-e71c-e063-6294a90ae837

Set id: 28dbe87b-1026-48b4-9093-b921b6c20e31

Version: 4

Effective Time: 20231007

Pure Source, LLC