Label: K2 COLD THERAPY- menthol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 18, 2014

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  • 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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