Label: MAGNIFICENT MENTHOL COOLING PAIN CREAM- menthol topical analgesic 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 January 14, 2022

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

  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical Analgesic

  • Warnings

    For external use only

  • When using this product

    Do not bandage tightly

    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not use with heating pads or other heating devices.
  • 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

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physicial or occupational therapist

    • children under 12 years of age: contact physical or occupational therapist
  • Inactive Ingredients:

    Butyrospermum Parkii (Shea

    Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol

    (CBD) Extract, Cetearyl Alcohol,

    Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera

    (Coconut) Oil, Deionized Water, Emulsifying Wax,

    Hamamelis Virginiana (Witch Hazel) Magnesium Chloride,

    Mangifera Indica (Mango) Seed Butter,

    Mentha piperita (Peppermint) Leaf Oil, Olea Europaea

    (Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Xanthan Gum

    Cooling Side Label

    Cooling top label

    BOX

  • INDICATIONS & USAGE

    Uses

    For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist.

  • PRINCIPAL DISPLAY PANEL

    MagNificent Box

  • INGREDIENTS AND APPEARANCE
    MAGNIFICENT MENTHOL COOLING PAIN CREAM 
    menthol topical analgesic cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-421
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 112 g
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CORN OIL (UNII: 8470G57WFM)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    WATER (UNII: 059QF0KO0R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-421-01112 g in 1 JAR; Type 0: Not a Combination Product12/06/2018
    2NDC:76348-421-02112 g in 1 BOX; Type 0: Not a Combination Product12/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/06/2018
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-421)