YOU PLUS RELIEF PAIN RELIEVING (MENTHOL) CREAM [THE FEEL GOOD LAB LLC]

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YOU PLUS RELIEF PAIN RELIEVING (MENTHOL) CREAM [THE FEEL GOOD LAB LLC]
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NDC 70554-848-34
Set ID de25d41b-8fbc-4d37-9e9d-97d5ab10667f
Category HUMAN OTC DRUG LABEL
Packager The Feel Good Lab LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • DRUG FACTS

  • Active Ingredient

    Menthol 1.25%

    Purpose

    Topical Analgesic

  • Indications

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

  • 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, get 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.
  • Additional Information:

    Store at room temperature

  • Other Ingredients:

    Achillea Millefolium (Yarrow) Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Annatto, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Beeswax, Boswellia Serrata Extract, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Myristoleate, Chondroitin Sulfate, Curcuma Longa (Turmeric) Root Extract, Gluconolactone, Glucosamine HCL, Glycerin Glyceryl Stearate, Harpagophytum Procumbens (Devil's Claw) Root Extract, Helianthus Annuus (Sunflower), Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Scutellaria Baicalensis (Skullcap) Root Extract, Sodium Benzoate, Sorbitan Olivate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Yucca Schidigera Extract.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    YOU PLUS RELIEF PAIN RELIEVING 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70554-848
    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)  
    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)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    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)  
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70554-848-34100 mL in 1 TUBE; Type 0: Not a Combination Product10/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/04/2017
    Labeler - The Feel Good Lab LLC (080160949)
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