WARMING EPSOM RUB (MENTHOL) GRANULE, FOR SOLUTION [CVS PHARMACY]

WARMING EPSOM RUB (MENTHOL) GRANULE, FOR SOLUTION [CVS PHARMACY]
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NDC 59779-672-43
Set ID 0675f6ae-43c1-4924-8c6b-d63365e4c8ee
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART348
  • active ingredients

    Menthol (1.25 w/w)

  • Purpose

    Topical Analgesic

  • Use

    for the temporry relief of minor aches and pains of muscle joints associated with simple backache, arthritis, strains, bruises, and sprains

  • Warnings

    For external use only

  • Flammable

    • keep away from fire or flame, heat, spark, electrical
  • When using this product

    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more then 7 days or clear up and occur again within a few days

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right way.

  • Directions

    adults and children 2 years of age and older  - apply to affected area not more than 3 to 4 times daily

    children under 2 years of age - consult a doctor

    Directions for Use as Relaxing Soak Solution:

    For external use only.  Pour Liberally into warm water no more than 4 times daily

  • Caution

    If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.  Individuals with diabetes should not use for hot or warm soaks unless advised by a physician.

  • Other information

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
    • will produce serious gastric distributances if taken internally
    • fumes can be acutely irritating to respiratory system.  Avoid inhaling this product
  • inactive ingredients

    water, isopropyl alcohol, Capsicum frutescens fruit extract, methyl salicylate, magnesium sulfate, red 40

  • Adverse reaction

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    CVS Pharmacy

    cvs.com 1-800-SHOP-CVS

  • PRINCIPAL DISPLAY PANEL

    CVS

    Health

    Menthol

    Warming

    Epsom Rub

    PAIN RELIEVING

    SOAKING SOLUTION

    TEMPORARILY RELIEVES PAING ASOCIATED WITH:

    • Arthritis
    • Minor aches
    • Sprains
    • Tired feet

    16 FL OZ ( 1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    WARMING EPSOM RUB 
    menthol granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-672
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAPSICUM (UNII: 00UK7646FG)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-672-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/05/2015
    Labeler - CVS Pharmacy (062312574)

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