EVELS SECRET NATURAL PAIN RELIEF DAREDEVIL STRENGTH (MENTHOL) GEL [NATURAL ESSENTIALS, INC.]

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EVELS SECRET NATURAL PAIN RELIEF DAREDEVIL STRENGTH (MENTHOL) GEL [NATURAL ESSENTIALS, INC.]
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NDC 66902-090-01, 66902-090-02, 66902-090-03, 66902-090-04, 66902-090-05, 66902-090-08, 66902-090-16, 66902-090-28
Set ID 4576656c-4b6e-6965-7665-6c4c69766573
Category HUMAN OTC DRUG LABEL
Packager NATURAL ESSENTIALS, INC.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol USP (Derived from Mentha Arvensis) 10.0%

  • Purpose

    External Analgesic

  • Uses

    • Temporarily relieves the minor aches and pains of muscles and joints associated with:
      • arthritis
      • strains
      • bruises
      • sprains
      • backache
  • Warnings:

    Use only as directed.

     
    - For external use only.

     
    - If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
     
    - Avoid contact with eyes or mucous membranes.

     
    - Pregnancy - Breast Feeding Warning: If pregnant or breast feeding, ask a physician before use.

     
    - Do not use with other topical products.
     
    - Do not use with heating devices.
     
    - Keep away from excessive heat or open flame.

     
    - KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN.
     
    - Accidental ingestion: Seek professional help and contact Poison Control immediately.
  • Directions:

    Adults and children 12 years and older

     
    - Apply and gently massage painful joints and/or muscles.
     
    - Repeat as needed.
     
    - Wash hands after each application with cold water.
  • Inactive ingredients

    Aloe, Glycerin, Magnesium Sulfate, Phenoxyethanol, Purified Water, SD Alcohol, Sodium Borate, Vitamin E (Tocopheryl Acetate), Xanthan Gum

  • Principal Display Panel - 4 oz. Container Label

    Evel Knievel

    Daredevil Strength Pain Relief!

    EVEL'S SECRET

    NATURAL PAIN RELIEF GEL

    Daredevil Strength

    NET WT 4 fl oz (118.29mL)

    Principal Display Panel - 4 oz. Container Label
  • INGREDIENTS AND APPEARANCE
    EVELS SECRET   NATURAL PAIN RELIEF DAREDEVIL STRENGTH
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-090
    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
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-090-04118.29 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:66902-090-0514.79 mL in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:66902-090-0129.57 mL in 1 CONTAINER; Type 0: Not a Combination Product
    4NDC:66902-090-0259.15 mL in 1 CONTAINER; Type 0: Not a Combination Product
    5NDC:66902-090-0388.72 mL in 1 CONTAINER; Type 0: Not a Combination Product
    6NDC:66902-090-08236.59 mL in 1 CONTAINER; Type 0: Not a Combination Product
    7NDC:66902-090-16473.18 mL in 1 CONTAINER; Type 0: Not a Combination Product
    8NDC:66902-090-283785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/15/2014
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-090)
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