Label: BRAZILIAN MENTHOL PAIN RELIEVING- 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 December 27, 2017

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

  • DRUG FACTS:

  • Active Ingredient:

    Menthol 10.00% 

    Topical Analgesic

  • Indications:

    For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

  • Warnings:

    • For external use only.
    • Avoid contact with eyes.
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    • If swallowed, consult physician.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

    If pregnant or breast feeding,

    contact physician prior to use.

  • Directions:

    • Adults and children two-years of age or older: Apply to affected  area not more than three to four times daily.
    •  Children under two-years of age: consult a physician.
  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Ascorbic Acid (Vitamin C), Boswellia Serrata  Extract, Cetearyl Olivate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, SD-Alcohol 40B, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    BRAZILIAN MENTHOL PAIN RELIEVING 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71977-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71977-126-041 in 1 BOX12/27/2017
    1118.294 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/27/2017
    Labeler - DDR Product, LLC (080781689)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(71977-126)