K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]

K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO]
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NDC 54633-201-13
Set ID 6ff293e6-951b-4b8d-8f62-9d7985f340b7
Category HUMAN OTC DRUG LABEL
Packager The Podiatree Co
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingrdient:

    Menthol 10%

  • PURPOSE

    PURPOSE

    TOPICAL ANALGESIC

  • INDICATIONS & USAGE

    TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

    • ARTHRITIS
    • SIMPLE BACKACHE
    • MUSCLE STRAINS
    • SPRAINS
  • WARNINGS

    For external use only.

    Flammable; Keep away from fire, sparks and heated surfaces

  • WHEN USING

    • Use only as directed
    • Do not bandage tighlty or use with a heating pad
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds or damaged, broken, or irritated skin.
  • STOP USE

    • Condition worsens
    • Redness is present
    • Irritation develops
    • Symptoms persist for more than 7 days or clear up and reoccur within a few days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • Adults and children 12 years of age and older: Apply a thin layer over the affected area not more than 3 to 4 times daily.
    • Children 12 years of age or younger: Consult a doctor.
    • Close cap tightly after use.
  • STORAGE AND HANDLING

    Store at controlled room temperature. Do not shake bottle with cap removed.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Camphor, Eucalyptus Globulus Leaf Oil, FD&C Blue #1, FD&C Yellow #5, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Oil, SD 40 Alcohol (5%) Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Steareth 2, Steareth 20, Urea, Vitis Vinifera (Grape) Seed Extract, Water (Purified)

  • QUESTIONS

    1.855.763.8733 or visit us at www.thepodiatreecompany.com

  • PRINCIPAL DISPLAY PANEL

    k2 Cold Therapy

  • INGREDIENTS AND APPEARANCE
    K2 COLD THERAPY 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
    ALCOHOL (UNII: 3K9958V90M)  
    SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    UREA (UNII: 8W8T17847W)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54633-201-1388.72 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/06/2014
    Labeler - The Podiatree Co (078656000)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMS Contract Packaging048602791manufacture(54633-201)

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