SANA SANA MENTHOL EXTERNAL ANALGESIC (MENTHOL) GEL [ALQUIMIA NAJULAM S DE RL DE CV]

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SANA SANA MENTHOL EXTERNAL ANALGESIC (MENTHOL) GEL [ALQUIMIA NAJULAM S DE RL DE CV]
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NDC 72367-000-00
Set ID 8b7edd51-e08a-4e01-9df0-8305ce17b418
Category HUMAN OTC DRUG LABEL
Packager Alquimia Najulam S de RL de CV
Generic Name
Product Class
Product Number
Application Number PART348
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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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