YOU RELIEF MUSCLE AND JOINT RUB (MENTHOL) CREAM [THE FEEL GOOD LAB, LLC]

YOU RELIEF MUSCLE AND JOINT RUB (MENTHOL) CREAM [THE FEEL GOOD LAB, LLC]
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NDC 70554-732-02
Set ID 759cabb4-04b1-4c0c-987c-c07e2e281abf
Category HUMAN OTC DRUG LABEL
Packager The Feel Good Lab, LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Drug Facts

  • Active ingredient

    Menthol 1.25%

    Purpose

    Topical pain relief

  • Indications

    For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • Warnings

    • For external use only.
    • Avoid contact with eyes.
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    If swallowed, consult physician.

    Do not apply

    to wounds or damaged skin.

    Do not bandage tightly.

    If pregnant or breast feeding,

    contact physician prior to use.

  • Directions

    • Adults and children two-years of age or older:

       Apply to affected area not more than three to four times daily.

    • Children under two-years of age: consult a physician.

  • Inactive ingredients

    achillea millefolium (yarrow) extract, aloe barbadensis (aloe vera gel) juice, aqua (deionized water), arnica montana (arnica) extract, beeswax, bixa orellana (annatto) seed extract, boswellia serrata extract, calendula officinalis (marigold) flower extract, caprylic/capric triglyceride, cetearyl olivate, cetyl myristoleate, chondroitin sulfate, curcuma longa (turmeric) extract, dimethyl sulfone (msm), emu oil, gluconolactone, glucosamine hcl, glycerin, glyceryl stearate se, harpagophytum procumbens (devil's claw) root extract, helianthus annuus (sunflower) seed oil, ilex paraguariensis (yerba mate) leaf extract, magnesium sulfate, scutellaria baicalensis (baikal skullcap) root extract, sodium benzoate, sorbitan olivate, stearic acid, tocopheryl acetate (vitamin e), xanthan gum, yucca aloifolia extract.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    YOU RELIEF MUSCLE AND JOINT RUB 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70554-732
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BIXA ORELLANA SEED (UNII: O87354RZ5A)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
    TURMERIC (UNII: 856YO1Z64F)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EMU OIL (UNII: 344821WD61)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70554-732-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/16/2016
    Labeler - The Feel Good Lab, LLC (080160949)

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