FDA Label for Oxyrub Pro Pain Relief Cream, 4oz

View Indications, Usage & Precautions

Oxyrub Pro Pain Relief Cream, 4oz Product Label

The following document was submitted to the FDA by the labeler of this product Healthy Directions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active Ingredients 

Menthol (2.5%)

Methyl Salicylate (10%)


Otc - Purpose



Purpose

Topical Analgesic 


Indications & Usage



Uses

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

  • simple backaches 
  • arthritis 
  • strains 
  • sprains 
  • bruises

Warnings



Warnings

For external use only:Use only as directed


Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



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


Otc - When Using



When using this product

  • avoid contact with eyes 
  • do not bandage tightly

Otc - Stop Use



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



Keep out of reach of children. 

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


Dosage & Administration



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



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


* Please review the disclaimer below.