Label: X RAY PAIN RELIEVING- menthol - 10.00% methyl salicylate - 15.00% 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 April 5, 2018

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  • Active ingredients                              Purpose

    Menthol-10% .................................... Topical Analgesic
    Methyl Salicylate -15% .....................Topical Analgesic

  • PURPOSE

  • Uses

    Temporary relief of minor aches and pains of muscles

    and joints associated with

    • simple backache
    • bruises
    • arthritis
    • sprains
    • strains
  • Warnings

    For external use only


    Do not use

    • on wounds or damaged, broken or irritated skin
    • with heating pad

    When using this product

    • use only as directed
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    Children under 12 years of age: Consult a doctor.

  • INACTIVE INGREDIENT

    Aminomethyl Propanol,Carbomer,Cetyl Alcohol,Glycerin,Glyceryl Stearate,Isopropyl Palmitate,Potassium Cetyl Phosphate,Stearic Acid,Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    X RAY PAIN RELIEVING 
    menthol - 10.00% methyl salicylate - 15.00% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol10 g  in 100 mL
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-501-031 in 1 CARTON12/15/2015
    189 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/15/2015
    Labeler - Genomma Lab (832323534)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(50066-501)
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