Label: PHOENIX KINETICREAM ANTI-INFLAMMATORY AND PAIN RELIEF- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Drug Facts

  • Active Ingredients

    Menthol 2.00%

    Purpose

    Topical Pain Relief

  • Uses

    temporary relieves of these symptoms:

    • minor aches
    • pains associated with simple backache
    • arthritis
    • bruises
    • sprains
    • cramps
    • muscle strains.
  • Warnings

    For external use only.

    • Use only as directed children under 6 years, ask a doctor.

    Stop use and ask a doctor if:

    • condition worsen
    • pain persist of more than 7 days
    • irritation develops

    Avoid contact with eyes and open wounds.

    If swallowed, get medical help or contact your local Poison Control Center or emergency room immediately.

    If pregnant or breast feeding

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    Adults and children 6 years and over:

    • Before activity, massage onto muscles and joints until absorbed into skin.
    • After activity, apply generously to tired and affected areas
    • Apply to dry and cleans areas
    • Repeat as needed, up to 6 times daily.
  • Inactive ingredients:

    Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), arnica montana (arnica) extract, azadirachta indica (neem) oil, bromelain, butyrospermum parkii (shea) butter, C13-14 isoparaffin, camellia sinensis (green tea) leaf extract, cetearyl alcohol, chondroitin sulfate, citric acid, citrus aurantium bergamia (bergamot) fruit oil, dimethyl sulfone (MSM), emu oil, ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate SE, laureth-7, mentha piperita (peppermint) oil, papain, phenoxyethanol, polyacrylamide, polysorbate-20, salix alba (willow) bark extract, SD-Alcohol 40B, sesamum indicum (sesame) seed oil, stearic acid, theobroma cacao (cocoa butter), tocopheryl acetate (vitamin E), xanthan gum.

  • Package Labeling:

    Tube

  • INGREDIENTS AND APPEARANCE
    PHOENIX KINETICREAM ANTI-INFLAMMATORY AND PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    BROMELAINS (UNII: U182GP2CF3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PAPAIN (UNII: A236A06Y32)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WILLOW BARK (UNII: S883J9JDYX)  
    SESAME OIL (UNII: QX10HYY4QV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-032-04118 mL in 1 TUBE; Type 0: Not a Combination Product02/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/22/2013
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-032)
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