Label: OXYRUB PAIN RELIEF- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • OxyRub Pain Relief Cream

  • Active Ingredient

    Menthol (1.25%)

  • Purpose

    Topical Analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints associated

    • simple backaches
    • arthritis
    • strains
    • sprains 
    • bruises
  • Warnings

    For external use only.

    Do not use

    redness over the affected area t Ask a doctor before use if you haveWhen using this produc

    Stop use and consult a doctor if

    • Use only as directed.
    • with a heating pad, may blister skin
    • on open wounds or damaged skin
    • Avoid contact with eyes
    • Do not bandage tightly
    • 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

    . Apply to affected area no more than 3-4 times daily. consult a doctor. Adults and children 12 years of age and olderChildren under 12 years of age,

  • Other information

    Store at room temperature. For Lot Number and Expiration Date, see crimp at end of tube.

  • Inactive Ingredients

    Bitter Orange Oil, C13-14 Isoparaffin, Caprylhydroxomic Acid, Caprylyl Glycol, Eucalyptus Oil, Glycerin, Laureth-7, Oxidized Corn Oil, Polyacrylamide (1000 MW), Polysorbate 20, Water

  • OxyRub Pain Relief Cream 4oz/114g (65121-113-04)

    OxyRub

  • INGREDIENTS AND APPEARANCE
    OXYRUB PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CORN OIL (UNII: 8470G57WFM)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-113-04114 g in 1 TUBE; Type 0: Not a Combination Product05/01/201312/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/201312/01/2020
    Labeler - Pure Source, LLC (080354456)
    Registrant - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-113)
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