FDA.reportPublic FDA data

OxyRub PRO Pain Relief Cream, 4oz

Manufacturer
Healthy Directions, LLC | Pure Source, LLC
Effective date
2017-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:22

Label at a glance#

ProductOxyRub Pro Pain Relief Cream, 4oz
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Label contents#

Full prescribing information#

Drug Facts 

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients 

Menthol (2.5%)

Methyl Salicylate (10%)

OTC - PURPOSE SECTION

Purpose

Topical Analgesic 

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: 

  • simple backaches 
  • arthritis 
  • strains 
  • sprains 
  • bruises

WARNINGS SECTION

Warnings

For external use only:Use only as directed

OTC - DO NOT USE SECTION

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin 

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes 
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and consult a doctor if

  • skin redness or excessive skin irritation develops
  • condition worsens or symptoms persist for more than 7 days 
  • symptoms clear up and occur again in a few days 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

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

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older: Apply to affected area no more than 3-4 times daily.

Children under 12 years of age: Consult a doctor. 

OTHER SAFETY INFORMATION

Other information 

Store at room termperature. For Lot Number and Expiration Date, see bottom of the carton or crimp at end of tube. 

INACTIVE INGREDIENT SECTION

Inactive ingredients C13-14 Isoparaffin,

Citrus Aurantium Dulcis (Orange) Oil,

Ethylhexylglycerin, Eucalyptus Globulus Oil,

Glyceryl Stearate, Laureth-7, Oxidized Corn

Oil, PEG-100 Stearate, Phenoxyethanol,

Polyacrylamide, Polysorbate-20, Water 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Pergolizzi 

OxyRub 

PRO

Pain Relief Cream

PROFESSIONAL STRENGTH 

MUSCLE & JOINT

PAIN RELIEF 

RAPIDLY

ABSORBED 

DEEP

PENETRATING 

Net Wt. 4 oz (114 g)

Distributed by 

HEALTHY DIRECTIONS 

6710A Rockledge Drive, Suite 500 

Bethesda, MD 20817

OxyRub PRO 4ozOxyRub PRO 4oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148131menthol 2.5 % / methyl salicylate 10 % Topical CreamPSN1
1148131menthol 25 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70015-655-042024-01-30C16284748780-11030e365-5436-111a-e063-dadaa90a10e2OxyRub PRO Pain Relief Cream, 4oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70015-655-04OxyRub Pro Pain ReliefCream, 4oz1 in 1 CARTONCREAM11
70015-655-04OxyRub Pro Pain ReliefCream, 4oz114 g in 1 TUBECREAM1141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70015-655OXYRUB PRO PAIN RELIEF CREAM, 4OZ (MENTHOL, METHYL SALICYLATE) CREAM [HEALTHY DIRECTIONS, LLC]1Legacy NDC, 2 package rows20170901_be26909d-afbb-4b89-a64a-fd130de223c7.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70015-65570015-655-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
ORANGE OILAKN3KSD11BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-7Z95S6G8201IACT
CORN OIL8470G57WFMIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)RHA9LWJ494IACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
C13-14 ISOPARAFFINE4F12ROE70IACT

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
d417edfb-86ce-4554-b1ce-ce126af62abbbe26909d-afbb-4b89-a64a-fd130de223c72017-08-15WarningsExact identifier
spl id: d417edfb-86ce-4554-b1ce-ce126af62abb
spl set id: be26909d-afbb-4b89-a64a-fd130de223c7

Reported adverse events (FAERS/openFDA)#

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