Label: EVELS SECRET NATURAL PAIN RELIEF DAREDEVIL STRENGTH- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 February 25, 2015

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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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