Label: SANA SANA MENTHOL EXTERNAL ANALGESIC- menthol gel

  • 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 June 7, 2018

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  • Drug Facts

  • Active ingredient

    Menthol 15%

    Purpose

    External Analgesic

  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with
    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains

  • Warnings

    For external use only

    Stop use and ask a doctor if

    • condition worsens

    • symptoms persist for more than 7 days or clear up and occur again within a few days

    When using this product

    • avoid contact with eyes

    • do not apply to wounds or damaged skin

    • do not bandage tightly

    Keep out of reach of children.

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

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

    • children under 2 years of age: consult a doctor

  • Inactive ingredients

    ionized water, glycerin, triethanolamine, carbopol

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    SANA SANA MENTHOL EXTERNAL ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72367-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72367-000-001 in 1 BOX06/22/2018
    1240 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/22/2018
    Labeler - Alquimia Najulam S de RL de CV (812839238)
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