Label: OXYRUB PRO PAIN RELIEF CREAM, 4OZ- menthol, methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 15, 2017

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  • Drug Facts 

    Active Ingredients 

    Menthol (2.5%)

    Methyl Salicylate (10%)

  • 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

    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. 

  • 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 

  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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