FDA.reportPublic FDA data

Pain Relieving Arthritis Cream

Manufacturer
Velocity Pharma LLC | Yash Pharmceuticals
Effective date
2017-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:04

Label at a glance#

ProductPain Relieving Arthritis
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure14 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Histamine dihydrochloride ...... 0.025%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Distributed by: Velocity Pharma LLC 
Farmingdale, NY, 11735

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relieving Arthritis Cream

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091387histamine dihydrochloride 0.025 % Topical CreamPSN2
1091387histamine dihydrochloride 0.25 MG/ML Topical CreamSCD2
1091387histamine dihydrochloride 0.025 % Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-108-452020-01-31C16284748780-19d75b9d0-d89d-f424-e053-dadaa90a57cePain Relieving Arthritis Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-108-45Pain Relieving Arthritis119 g in 1 JARCREAM1192

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-108PAIN RELIEVING ARTHRITIS (HISTAMINE DIHYDROCHLORIDE) CREAM [VELOCITY PHARMA LLC]2Legacy NDC, 1 package rows20170302_80f404f6-5ee5-401d-8c02-c6f49f344f3c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76168-10876168-108-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
DISODIUM HYDROGEN CITRATE6FO62KCQ7AIACT
EDETATE SODIUMMP1J8420LUIACT
PARAFFINI9O0E3H2ZEIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBIC ACIDX045WJ989BIACT
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
49b0ece6-584a-7133-e054-00144ff8d46c80f404f6-5ee5-401d-8c02-c6f49f344f3c2017-03-01WarningsExact identifier
spl id: 49b0ece6-584a-7133-e054-00144ff8d46c
spl set id: 80f404f6-5ee5-401d-8c02-c6f49f344f3c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.