EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]

EFAC PAIN RELIEVING (MENTHOL) CREAM [IMAGENETIX]
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NDC 55722-419-02
Set ID 84057a2f-f16f-4b0f-ab28-ee7e3fa472a3
Category HUMAN OTC DRUG LABEL
Packager Imagenetix
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Menthol (1.25%)

  • Purpose

    Topical Analgesic

  • Indications

    For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

  • Warnings


    • For external use only.

       

    • Avoid contact with eyes.

    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

    • Do not apply to wounds or damaged skin.

    • Do not bandage tightly.

    • Keep out of reach of children.

       

    • If swallowed, get medical help or contact a poison control center right away.
  • Directions

    Adults and children 2 yrs. of age and older, apply to affected area not more than 3 to 4 times a day. Children under 2 yrs. of age, consult a physician.

  • Other Information

    Store in a cool, dry place.

  • Inactive Ingredients

    Benzyl Alcohol, Butylparaben, Carbomer, Esterified Fatty Acids (Proprietary Blend), Ethylparaben, Glycerin, Glyceryl Stearate, Isobutylparaben, Lecithin, Methylparaben, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Peppermint Oil, Phenoxyethanol, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Water.

  • Questions?

    1-866-628-8725
    www.HopeScience.com

  • SPL UNCLASSIFIED SECTION

    Distributed by Hope Science Inc.

  • PRINCIPAL DISPLAY PANEL - 113G Jar Label

    Clinically
    Tested MORE
    Effective

    TOPICAL
    ANALGESIC

    Esterified Fatty Acid Complex

    EFAC
    Pain Relieving
    Cream

    FEEL the Difference!

    4 OZ. (113G)
    MAXIMUM ABSORPTION

    Principal Display Panel - 113G Jar Label
  • INGREDIENTS AND APPEARANCE
    EFAC   PAIN RELIEVING
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55722-419
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol12.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55722-419-02113 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2012
    Labeler - Imagenetix (091209341)
    Registrant - Lifetech Resources, LLC (662559110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources, LLC622559110MANUFACTURE(55722-419)

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