WARMING EPSOM RUB (MENTHOL) GRANULE, FOR SOLUTION [VI-JON, INC]

WARMING EPSOM RUB (MENTHOL) GRANULE, FOR SOLUTION [VI-JON, INC]
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NDC 0869-0672-43
Set ID d5928fd2-91fb-45fb-b57e-b1fb54fd8921
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • active ingredients

    Menthol

  • 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.  Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician.  Keep out of reach of children.

  • Other information

    • does not conain, 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

    Manufactured by: Vi-Jon Inc.  St. Louis MO 63114

    672.000/672AA

  • principal display panel

    mountain

    falls

    relaxing

    soak

    solution

    penetrating

    pain

    relied

    permeating heat

    sports rub

    pain relieving &

    soaking solution

    temporarily relieves pains

    associated with:

    • arthritis
    • minor muscular aches
    • aching joints

    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:0869-0672
    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:0869-0672-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2017
    Labeler - Vi-Jon, LLC (790752542)

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