{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 15
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Dr Sabharwals Menthol 5% Patch POVIDONE PARAFFINUM LIQUIDUM CARBOXYMETHYLCELLULOSE SODIUM ALUMINIUM SULFATE OCTADECAHYDRATE BORAX PROPYLENE GLYCOL DIHYDROXYALUMINUM AMINOACETATE BUTYLATED HYDROXYTOLUENE WATER SODIUM POLYACRYLATE (8000 MW) SORBITAN MONOOLEATE POLYACRYLIC ACID (250000 MW) TITANIUM DIOXIDE ALUMINUM HYDROXIDE POLYVINYL ALCOHOL (100000 MW) ALPHA-TOCOPHEROL ACETATE TARTARIC ACID KAOLIN MENTHOL MENTHOL DMDM HYDANTOIN GLYCERIN EDETATE DISODIUM"
      ],
      "active_ingredient": [
        "Menthol 5%"
      ],
      "purpose": [
        "Topical Analgesic"
      ],
      "indications_and_usage": [
        "Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache, arthritis, strains, bruises and sprains"
      ],
      "warnings": [
        "For external use only"
      ],
      "do_not_use": [
        "more than 1 patch on your body at a time on cut, irritated or swollen skin on puncture wounds or damaged skin for more than one week without consulting a doctor with heating pad on a child under 12 yeas of age with arthritis-like conditions"
      ],
      "when_using": [
        "use only as directed. read and follow all directions and warnings on this label rare cases of serious burns have been reported with products of this type. do not apply to wounds or damaged, broken or irritated skin do not allow contact with eyes and mucous membranes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch a transient burning sensation may occur upon application but generally disappears in several days if a severe burning sensation occurs, discontinue use immediately. discontinue use at least 1 hour before a bath or shower. do not use immediately after a bath or shower."
      ],
      "ask_doctor": [
        "condition worsens redness is present over the affected area excess skin irritation occurs symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury such as pain, swelling, or blistering where the product was applied"
      ],
      "pregnancy_or_breast_feeding": [
        "if pregnanat or breast feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "keep out of reach of children and pets if swallowed, get medical help or contact a Poison Control Center right away"
      ],
      "instructions_for_use": [
        "Adult and children over 12years: Clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area do not wear a patch for more than 8 hours apply affected area no more than 3 times daily children 12 years or younger: ask a doctor"
      ],
      "storage_and_handling": [
        "Store at room temperature 20-25 0 C (68-77 0 F)"
      ],
      "questions": [
        "Call +91-905-677-0088"
      ],
      "inactive_ingredient": [
        "Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide."
      ],
      "dosage_and_administration": [
        "Topical Pain Relief Patch of External Use Only"
      ],
      "package_label_principal_display_panel": [
        "Menthol 5% Patch"
      ],
      "set_id": "1025b986-a1e5-701d-e063-6294a90a33fd",
      "id": "491e6a6d-0f22-8feb-e063-6294a90abc3d",
      "effective_time": "20260124",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Dr Sabharwals"
        ],
        "generic_name": [
          "MENTHOL 5% PATCH"
        ],
        "manufacturer_name": [
          "Dr. Sabharwal's Wound Care"
        ],
        "product_ndc": [
          "71318-116"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL"
        ],
        "rxcui": [
          "420222"
        ],
        "spl_id": [
          "491e6a6d-0f22-8feb-e063-6294a90abc3d"
        ],
        "spl_set_id": [
          "1025b986-a1e5-701d-e063-6294a90a33fd"
        ],
        "package_ndc": [
          "71318-116-15"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L7T10EIP3A"
        ]
      }
    }
  ]
}