Label: RELIEF AND COOLING- 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 August 23, 2019

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  • Drug facts

  • ACTIVE INGREDIENT

    Active ingredient

    Menthol USP 3.7%

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses temporarily relieves minor aches and pains of muscles and joints due to

    • arthritis
    • simple backaches
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    For external use only Flammable: Keep away from fire or flame.

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • with other ointments, creams, sprays or liniments
  • WHEN USING

    When using this product

    • avoid contact with eyes
    • do not bandage tightly
    • wash hands with cool water after use
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or rash or irritation develops
    • symptoms last more than 7 days
    • condition clears up and occurs again within a few days
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age and older: apply and massage onto affected area no more than 3 to 4 times daily
    children under 12 years of age: ask a doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    • close cap tightly
    • store in a cool, dry place
  • INACTIVE INGREDIENT

    Inactive ingredients Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Carbomer, Dimethyl Sulfone(MSM), EDTA, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca Altemifolia (Tea Tree) Leaf Oil, Pyridoxine HCl (Vitamins B6), Phenoxyethanol & Methyl/Ethyl/Butyl/Propyl/Isobutylparabens, Polysorbate 20, Purified Water, Tocopheryl (Vitamin E) Acetate, Triethanolamine

  • SPL UNCLASSIFIED SECTION

    FORMULATED BY NUTRANEXT

    DISTRIBUTED BY NUTRANEXT DIRECT, LLC, SUNRISE, FL 33323

    800-270-5771

  • PRINCIPAL DISPLAY PANEL

    Relief + Cooling

    MENTHOL JOINT & MUSCLE SOOTHER

    HOW IT WORKS

    Menthol cream quickly stops aches and pains - no greasy residue, no lingering odor.

    PAIN RELIEF

    NET WT 3 OZ (85 G)

    label

  • INGREDIENTS AND APPEARANCE
    RELIEF AND COOLING 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72914-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL (UNII: Y050HYR4XA)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72914-0002-285 g in 1 JAR; Type 0: Not a Combination Product08/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/23/2019
    Labeler - Nutranext LLC (968031174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupack Midwest139637433manufacture(72914-0002)
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