{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Chamosyn Paraben Free Barrier Cream ALOE VERA LEAF FERRIC OXIDE RED CAPRYLYL GLYCOL CHAMOMILE COD LIVER OIL EDETATE DISODIUM ETHYLHEXYLGLYCERIN GLYCERIN LANOLIN LIGHT MINERAL OIL HONEY MICROCRYSTALLINE WAX PETROLATUM PHENOXYETHANOL SODIUM BORATE SORBITAN MONOOLEATE TOCOPHEROL WATER MENTHOL MENTHOL ZINC OXIDE ZINC OXIDE Chamosyn Barrier Cream ALOE VERA LEAF FERRIC OXIDE RED CHAMOMILE COD LIVER OIL EDETATE DISODIUM GLYCERIN LANOLIN LIGHT MINERAL OIL HONEY METHYLPARABEN MICROCRYSTALLINE WAX PETROLATUM PROPYLPARABEN SODIUM BORATE SORBITAN MONOOLEATE TOCOPHEROL WATER MENTHOL MENTHOL ZINC OXIDE ZINC OXIDE Chamosyn Barrier Cream SODIUM BORATE SORBITAN MONOOLEATE TOCOPHEROL WATER MENTHOL MENTHOL ZINC OXIDE ZINC OXIDE ALOE VERA LEAF FERRIC OXIDE RED CHAMOMILE COD LIVER OIL EDETATE DISODIUM GLYCERIN LANOLIN LIGHT MINERAL OIL HONEY METHYLPARABEN MICROCRYSTALLINE WAX PETROLATUM PROPYLPARABEN"
      ],
      "active_ingredient": [
        "Active ingredients Menthol 0.45% or 0.1% Zinc oxide 20%"
      ],
      "purpose": [
        "Purpose Anorectal analgesic/Anti-itch Skin protectant"
      ],
      "indications_and_usage": [
        "Uses Helps relieve the local discomfort, burning, and itching of the perianal area associated with anorectal disorders and inflamed hemorrhoidal tissues. Aids in protecting irritated anorectal areas. Dries the oozing and weeping of poison ivy oak sumac"
      ],
      "warnings": [
        "Warnings For external use only. When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms do not improve within 7 days or clear up and occur again within a few days. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any medical device or applicator. Certain persons can develop allergic reactions to this product. If symptoms do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with clean tissue or a clean soft cloth before application of this product. Children under 12 years of age: consult a doctor. Apply externally to the affected area as needed up to 6 times daily or after each incontinence episode or diaper change."
      ],
      "other_safety_information": [
        "Other information Protect from freezing, avoid excessive heat."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Chamosyn Active aloe gel, Calamine, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Glycerin, Lanolin, Light mineral oil, Manuka honey, Methylparaben, Microcrystalline wax, Petrolatum, Propylparaben, Sodium borate, Sorbitan oleate, Tocopherol, Water Chamosyn - Paraben Free Active aloe gel, Calamine, Caprylyl glycol, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Ethylhexylglycerin, Glycerin, Lanolin, Light mineral oil, Manuka honey, Microcrystalline wax, Petrolatum, Phenoxyethanol, Sodium borate, Sorbitan oleate, Tocopherol, Water"
      ],
      "questions": [
        "Questions? (888) 425-1149"
      ],
      "package_label_principal_display_panel": [
        "Chamosyn Ointment (0.45% Menthol) Tube Label Packet Labels 001_Tube 001_Packets 001_Packet Box",
        "Chamosyn Ointment (0.45% Menthol) - Paraben Free Tube Label Packet Labels 51028-003-01 Tube Label 51028-003-00 Packet Label 51028-003-00 Packet Box Label",
        "Chamosyn Ointment (0.1% Menthol) Tube Label 002_Chamosyn"
      ],
      "set_id": "f9dfb2d7-4684-4525-994e-1e0ff90413d9",
      "id": "34a97f44-835c-ebb7-e063-6294a90a5b67",
      "effective_time": "20250508",
      "version": "8",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Chamosyn",
          "Chamosyn Paraben Free"
        ],
        "generic_name": [
          "BARRIER CREAM"
        ],
        "manufacturer_name": [
          "Links Medical Products"
        ],
        "product_ndc": [
          "51028-002",
          "51028-003",
          "51028-001"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "884804",
          "1998442",
          "2730301"
        ],
        "spl_id": [
          "34a97f44-835c-ebb7-e063-6294a90a5b67"
        ],
        "spl_set_id": [
          "f9dfb2d7-4684-4525-994e-1e0ff90413d9"
        ],
        "package_ndc": [
          "51028-003-00",
          "51028-003-01",
          "51028-001-00",
          "51028-001-01",
          "51028-002-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L7T10EIP3A",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}