Label: INSPIRATION ACADEMY MENTHOL COOLING PAIN CREAM- menthol 5 percent cream

  • NDC Code(s): 76348-900-01, 76348-900-04
  • Packager: Renu Laboratories, Inc.
  • 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 3, 2022

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Menthol 5%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • PURPOSE

    Purpose

    Topical Analgesic

  • QUESTIONS

    Questions or Comments

    PHONE: (941) 795-5466 (LION)

  • STOP USE

    Stop use and ask a doctor if

    condition worsens or if symptoms persist for more than seven days or clear up and occur again within a few days

  • WHEN USING

    When using this product:

    • Do not bandage tightly
    • avoid contact with eye
    • do not apply to wounds or damaged skin
    • do not use heating pads or other heating devices.
  • DOSAGE & ADMINISTRATION

    Directions:

    adults and children 12 years of age and older

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary
  • INACTIVE INGREDIENT

    Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter,

    Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water,

    Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil,

    Laureth-7, Lobelia Inflata (Lobelia) Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea europaea (Olive) Oil,

    Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Xanthan Gum.

  • INDICATIONS & USAGE

    Uses:

    for temporary relief of minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, bruises and arthritis.

  • WARNINGS

    For external use only

  • PRINCIPAL DISPLAY PANEL

    IA BOX ARTPACKAGE LABEL AND BOX ART

    IA Cream Label

  • INGREDIENTS AND APPEARANCE
    INSPIRATION ACADEMY MENTHOL COOLING PAIN CREAM 
    menthol 5 percent cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-900
    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
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LOBELIA INFLATA (UNII: 9PP1T3TC5U)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CORN OIL (UNII: 8470G57WFM)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MAGNESIUM OROTATE (UNII: GI96W46M5A)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-900-011 in 1 BOX11/08/2021
    1NDC:76348-900-04112 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/08/2021
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-900)