Label: ACTIVATE JOINT AND MUSCLE RELIEF- lidocaine hydrochloride, menthol cream

  • NDC Code(s): 71868-080-01
  • Packager: Liberty Health Supply, LLC
  • Category: HUMAN OTC DRUG LABEL

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 November 6, 2017

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  • Drug Facts

  • Active Ingredients

    4.00% Lidocaine HCl 
    1.00% Menthol

    Purpose

    Topical Anesthetic

  • Indications:

    For the temporary relief of pain and itching due to minor burns, sunburn, minor cuts, scrapes, insect bites and minor skin irritations

  • Warnings:

    • For external use only.
    • Do not use in large quantities, particularly over raw or blistered areas.
    • If symptoms persisit for more than seven days, discontinue use and consult physician.
    • Avoid contact with eyes. Rinse well if contact occurs

    Keep out of reach of children.

    • If swallowed, consult physician.
  • Directions:

    • Adults and children two-years of age or older: Apply small amount to affected area not more than three to four times daily.
    • Apply after shower or bath for best result
    • Children under two-years of age: consult a physician
  • Additional information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Azadirachta Indica (Neem) Oil,  Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Calophyllum Inophyllum (Tamanu) Seed Oil, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Emu Oil, Ethylhexylglycerin, Glycerin,
    Glyceryl Stearate, Glucosamine Sulfate, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Sesamum
    Indicum (Sesame) Seed Oil, SD-Alcohol 40B, Stearic Acid, Tocopheryl Acetate (Vitamin E), Theobroma Cacao (Cocoa) Butter, Xanthan Gum.

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    ACTIVATE JOINT AND MUSCLE RELIEF 
    lidocaine hydrochloride, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71868-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SESAME OIL (UNII: QX10HYY4QV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71868-080-011 in 1 BOX11/01/2017
    1118.294 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2017
    Labeler - Liberty Health Supply, LLC (080886320)