PAIN RELIEVING ARTHRITIS- histamine dihydrochloride cream

Pain Relieving Arthritis by

Drug Labeling and Warnings

Pain Relieving Arthritis by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma LLC, Yash Pharmceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Histamine dihydrochloride ...... 0.025%

Purpose

External Analgesic

Uses

• For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains & bruises.

Warnings

• For external use only.
• Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.

When using this product

• avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
• do not bandage tightly or use a heating pad.

Stop use and ask a doctor if

• rash appears.
• condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For Use by Adults and Children over 12 years.
• Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.
• Children 12 years or younger consult a physician.

Other information

• Store between 40°F and 86°F ( 4°C and 30C).
• Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive ingredients

butylated hydroxyl toluene, cetostearyl alcohol , cetomacrogol 1000, cetyl alcohol, disodium EDTA, disodium hydrogen phosphate, light liquid paraffin, propylene glycol, sorbic acid, transquitol P, white petroleum jelly

Questions or Comments? Call 1855-314-1850

Distributed by: Velocity Pharma LLC 
Farmingdale, NY, 11735

PRINCIPAL DISPLAY PANEL

Pain Relieving Arthritis Cream

Net Wt. 4 oz (119g)

INGREDIENTS AND APPEARANCE

PAIN RELIEVING ARTHRITIS 
histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-108
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)
EDETATE SODIUM (UNII: MP1J8420LU)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-108-45	119 g in 1 JAR; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2017

Labeler - Velocity Pharma LLC (962198409)

Registrant - Velocity Pharma LLC (962198409)

Establishment
Name	Address	ID/FEI	Business Operations
Yash Pharmceuticals		871409551	manufacture(76168-108)

Establishment
Name	Address	ID/FEI	Business Operations
Velocity Pharma LLC		962198409	label(76168-108)