Label: MIRACLE PAIN CREAM- menthol cream

  • 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 October 2, 2013

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  • ACTIVE INGREDIENT

    Menthol 3.0%

  • PURPOSE

    Topical analgesic

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center right away.

  • USES

    temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps
  • WARNINGS

    for external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with heating pad
    • avoid contact with the eyes or mucous membranes
    • do not apply to wounds or damaged skin

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding

    ask a health professional before use

  • DIRECTIONS

    Adults and children over 12 years

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into the skin
    • repeat as necessary, no more than 4 times daily

    Children 12 years or younger

    ask a doctor

  • INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf, Arnica Montana Flower Extract, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Cymbopogon Martinii (Palmarosa) Oil, Eucalyptus Globulus Leaf Oil, Hamamelis Virginiana (Witch Hazel) Bark / Leaf / Twig Extract, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, Sorbitol, Tocopheryl Acetate, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    Display Panel
  • INGREDIENTS AND APPEARANCE
    MIRACLE PAIN CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) menthol3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    SORBITOL (UNII: 506T60A25R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-049-04115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2012
    Labeler - Cosmetic Specialty labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty labs, Inc.032973000manufacture(58133-049)
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