EFAC PAIN RELIEVING CREAM (MENTHOL, UNSPECIFIED FORM) CREAM [HOPE SCIENCE INC.]

  • Home
  • EFAC PAIN RELIEVING CREAM (MENTHOL, UNSPECIFIED FORM) CREAM [HOPE SCIENCE INC.]

EFAC PAIN RELIEVING CREAM (MENTHOL, UNSPECIFIED FORM) CREAM [HOPE SCIENCE INC.]
PDF | XML
NDC 71970-300-45, 71970-300-49
Set ID 2a0d375f-1dcd-4498-aab5-09ea11157439
Category HUMAN OTC DRUG LABEL
Packager Hope Science Inc.
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • 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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylyl Glycol, Citric Acid, Esterified Fatty Acids (EFAC Proprieatry Blend), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Lecithin, Mentha Piperita (Peppermint) Oil, PEG-100 Stearate, Phenoxyethanol, Sodium Hydroxide, Tocopheryl Acetate, Water.

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by Hope Science Inc.

  • PRINCIPAL DISPLAY PANEL - 16 oz. Tube Label

    FEEL the Difference!

    Clinically Tested MORE Effective

    EFAC

    PAIN Relieving Cream
    TOPICAL ANALGESIC

    16 oz.

    Maximum Absorption!

    Principal Display Panel - 16 oz. Tube Label
  • INGREDIENTS AND APPEARANCE
    EFAC   PAIN RELIEVING CREAM
    menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71970-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM12.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CETYL TALLOWATE (UNII: MVY7P518D2)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71970-300-45113 g in 1 JAR; Type 0: Not a Combination Product03/01/2018
    2NDC:71970-300-49454 g in 1 TUBE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/01/2018
    Labeler - Hope Science Inc. (049917199)
    Registrant - Lifetech Resources LLC (622559110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources LLC622559110MANUFACTURE(71970-300)
View All Sections

Related Drugs

Search DailyMed Drugs