PAIN RELIEVING ARTHRITIS- histamine dihydrochloride cream 
Velocity Pharma LLC

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.

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Pain Relieving Arthritis Cream

Drug Facts

Active Ingredient

Histamine dihydrochloride ...... 0.025%

Purpose

External Analgesic

Uses

Warnings

When using this product

Stop use and ask a doctor if

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

Other information

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

Pain Relieving Arthritis Cream

Net Wt. 4 oz (119g) Arthritis Pain Relief Cream

PAIN RELIEVING ARTHRITIS 
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-108-45119 g in 1 JAR; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2017
Labeler - Velocity Pharma LLC (962198409)
Registrant - Velocity Pharma LLC (962198409)
Establishment
NameAddressID/FEIBusiness Operations
Yash Pharmceuticals871409551manufacture(76168-108)
Establishment
NameAddressID/FEIBusiness Operations
Velocity Pharma LLC962198409label(76168-108)

Revised: 3/2017
Document Id: 49b0ece6-584a-7133-e054-00144ff8d46c
Set id: 80f404f6-5ee5-401d-8c02-c6f49f344f3c
Version: 2
Effective Time: 20170301
 
Velocity Pharma LLC