X RAY PAIN RELIEVING (MENTHOL - 10.00% METHYL SALICYLATE - 15.00%) CREAM [GENOMMA LAB]

X RAY PAIN RELIEVING (MENTHOL - 10.00% METHYL SALICYLATE - 15.00%) CREAM [GENOMMA LAB]
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NDC 50066-501-03
Set ID 895f3cc0-719b-4553-a49e-021ceee65a7d
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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