Label: COLD THERAPY PAIN RELIEF MEIJER- menthol 4% 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 July 12, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                   Purpose
    Menthol 4%..........................................................Topical Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses
    Temporary relief of minor aches and pains of muscles and joints
    associated with arthritis, simple backache, strains and sprains

  • WARNINGS

    Warnings
    For external use only.
    When using this product • avoid contact with the eyes or mucous
    membranes • do not apply to wounds or damaged skin • do not
    apply to the irritated skin or if excessive irritation develops • do not
    bandage • do not use with heating pad or device
    Stop use and ask a doctor if • condition worsens, or if symptoms
    persist for more than 7 days, or clear up and occur again within a
    few days.
    If pregnant or breastfeeding ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If accidentally ingested get
    medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions
    • Adults and children 12 years of age and older: Apply on to the
    affected areas not more than 3-4 times daily.
    • Children under 12 years of age: Consult physician

  • OTHER SAFETY INFORMATION

    Other information
    Store in a cool dry place with lid closed tightly

  • INACTIVE INGREDIENT

    Inactive ingredients
    Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock)
    Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin
    Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract,
    Camphor, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Ilex
    Paraguariensis (Mate) Leaf Extract, Isopropyl Alcohol, Isopropyl
    Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica,
    Tocopheryl Acetate, Triethanolamine, Water.

  • QUESTIONS

    Questions? 866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    COLD THERAPY PAIN RELIEF  MEIJER
    menthol 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-787
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Glycerin (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-787-0385 g in 1 TUBE; Type 0: Not a Combination Product07/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/11/2018
    Labeler - Meijer (006959555)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41250-787) , label(41250-787)