OXYRUB PRO PAIN RELIEF CREAM, 4OZ- menthol, methyl salicylate cream 
Healthy Directions, 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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OxyRub PRO Pain Relief Cream, 4oz

Drug Facts 

Active Ingredients 

Menthol (2.5%)

Methyl Salicylate (10%)

Purpose

Topical Analgesic 

Uses

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

Warnings

For external use only:Use only as directed

Do not use

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

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

When using this product

  • avoid contact with eyes 
  • do not bandage tightly

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 

Keep out of reach of children. 

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

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 information 

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

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 

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 4oz

OXYRUB PRO PAIN RELIEF  CREAM, 4OZ
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70015-655
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25.0 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100.0 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ORANGE OIL (UNII: AKN3KSD11B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-7 (UNII: Z95S6G8201)  
CORN OIL (UNII: 8470G57WFM)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70015-655-041 in 1 CARTON09/01/2017
1114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2017
Labeler - Healthy Directions, LLC (150261183)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(70015-655)

Revised: 8/2017
Document Id: d417edfb-86ce-4554-b1ce-ce126af62abb
Set id: be26909d-afbb-4b89-a64a-fd130de223c7
Version: 1
Effective Time: 20170815
 
Healthy Directions, LLC