Oxyrub Pro Pain Relief
FDA Label NDC 70015-655

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healthy Directions, Llc for the product Oxyrub Pro Pain Relief (NDC 70015-655). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Oxyrub Pro 4oz (Oxyrubpro4oz)

Oxyrub Pro 4oz (Oxyrubpro4oz)

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