Label: MIRACLE ICE ULTRA STRENGTH (menthol and camphor- synthetic 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 September 20, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Menthol 1%Topical analgesic
    Camphor 0.5%Topical analgesic
  • Uses

    • temporarily relieves minor aches and pains of muscles and joints associated with:
      • arthritis
      • simple backache
      • strains
      • bruises
      • sport injuries
      • sprains
  • Warnings

    For external use only

    Do not use

    • with other topical pain relievers
    • with heating pads or heating devices

    When using this product

    • do not use in or near the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • redness or irritation develops

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean affected area before applying product
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
    • children under 2 years of age: ask a doctor
  • Other information

    • Store at room temperature 59°-86°F (15°-30°C).
    • Keep jar tightly closed and away from open heat or flame
  • Inactive ingredients

    Aqua, Propylene Glycol, Carbomer, Methyl Salicylate, Sodium Hydroxide, Sodium Methyl Paraben, Sodium Propyle Paraben, CI 14720, CI 16185, CI 42090

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    FDN Enterprises, LLC.
    Opa Locka, FL 33054

  • PRINCIPAL DISPLAY PANEL - 227 g Jar Label

    FDN Medical®
    MIRACLE
    ICE

    ULTRA STRENGTH

    ANALGESIC GEL

    NET WT. 8 OZ (227 g)

    PRINCIPAL DISPLAY PANEL - 227 g Jar Label
  • INGREDIENTS AND APPEARANCE
    MIRACLE ICE   ULTRA STRENGTH
    menthol and camphor (synthetic) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60691-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1 g  in 100 g
    Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET) Camphor (synthetic)0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Methylparaben Sodium (UNII: CR6K9C2NHK)  
    Propylparaben Sodium (UNII: 625NNB0G9N)  
    Carmoisine (UNII: DR4641L47F)  
    Amaranth (UNII: 37RBV3X49K)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60691-116-30227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34807/15/2013
    Labeler - FDN Enterprises,LLC (965743867)
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