DAREDEVIL STRENGTH MUSCLE AND ARTHRITIS PAIN RELIEVING (MENTHOL) GEL [DDR PRODUCTS, LLC]

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DAREDEVIL STRENGTH MUSCLE AND ARTHRITIS PAIN RELIEVING (MENTHOL) GEL [DDR PRODUCTS, LLC]
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NDC 71977-011-04, 71977-011-05
Set ID 9a8e0e3d-b56b-420a-ae7c-cc53460ef1ec
Category HUMAN OTC DRUG LABEL
Packager DDR Products, LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • DRUG FACTS

  • Active Ingredient:

    Menthol 10.00%

    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 od 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.

  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Carbomer, Glycerin, Magnesium Sulfate, Phenoxyethanol, SD-Alcohol 40B, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

  • DAREDEVIL STRENGTH Muscle & Arthritis Pain Relieving Gel

    Label2

  • DAREDEVIL STRENGTH Muscle & Arthritis Pain Relieving Gel

    Label3

  • INGREDIENTS AND APPEARANCE
    DAREDEVIL STRENGTH MUSCLE AND ARTHRITIS PAIN RELIEVING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71977-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71977-011-04118.29 mL in 1 JAR; Type 0: Not a Combination Product10/25/2018
    2NDC:71977-011-055 mL in 1 PACKET; Type 0: Not a Combination Product10/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/25/2018
    Labeler - DDR Products, LLC (080781689)
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