Label: LIGHTNING PAIN RELIEF- menthol cream

  • NDC Code(s): 63742-013-00, 63742-013-01
  • Packager: Clinical Resolution Laboratory, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2024

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

  • DRUG FACTS

  • Active Ingredient

    Menthol 4%

    Purpose

    Topical Analgesic

  • Uses:

    • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
    • Provides cooling and warming pain relief.
  • Warnings

    • For external use only.
    • Avoid contact with the eyes.
    • 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 doctor.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

    Keep out of reach od children.

    • In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

    Do not use this product

    if seal is broken or missing.

  • Directions

    • 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: consult a doctor.
  • Other Information

    • Keep away from direct sunlight or heat.
    • Store at room temperature 15°-30° C (59°-86°F).
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Resin Extract, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa Seed Oil, Carbomer, Centella Asiatica Leaf Extract, Cinnamomum Camphora (Camphor) Bark Oil, Dimethicone, Dimethyl Isosorbide, Dipotassium Glycyrrhizate, Disodium EDTA, Emu Oil, Ethoxydiglycol, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methyl Sulfonyl Methane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 20, Pyridoxine HCL, Sodium Benzoate, Tocopheryl Acetate, Triethanolamine, Water

  • Package Labeling:

    Label

  • Package Labeling:101g

    Label2

  • INGREDIENTS AND APPEARANCE
    LIGHTNING PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    EMU OIL (UNII: 344821WD61)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63742-013-0065 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    2NDC:63742-013-01101 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2019
    Labeler - Clinical Resolution Laboratory, Inc. (825047942)