Label: BRAZILIAN MENTHOL PAIN RELIEVING ROLL ON- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • 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:

    Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Ascorbic Acid (Vitamin C), Boswellia Serrata Extract, Carbomer, Magnesium Sulfate, Methylisothiazolinone, Methylsulfonylmethane (MSM), Polysorbate-20, SD-Alcohol 40B, Triethanolamine.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BRAZILIAN MENTHOL PAIN RELIEVING ROLL ON 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71977-125
    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)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71977-125-0488.72 mL in 1 BOTTLE; Type 0: Not a Combination Product12/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/27/2017
    Labeler - DDR Product, LLC (080781689)
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