{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Insect sting relief latex 01 sodium bicarbonate YELLOW WAX GLYCERYL MONOSTEARATE PROPYLPARABEN CETOSTEARYL ALCOHOL EDETATE DISODIUM GLYCERIN SODIUM BICARBONATE BICARBONATE ION WATER ALOE VERA LEAF PHENOXYETHANOL METHYLPARABEN MINERAL OIL CETETH-25 BUTYLATED HYDROXYTOLUENE"
      ],
      "spl_unclassified_section": [
        "Drug Fact"
      ],
      "active_ingredient": [
        "Active Ingredient Sodium bicarbonate (Baking Soda) 5%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses temporary protects and helps relieve minor skin irritation and itching due to: poison ivy, oak, or sumac insect bites"
      ],
      "warnings": [
        "Warnings For external use only. Do not use in or near the eyes for diaper rash; ask a doctor Ask a doctor before use if you are using any other hydrocortisone product Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. Keep out of reach of children if ingested, contact a poison control center right away."
      ],
      "do_not_use": [
        "Do not use in or near the eyes for diaper rash; ask a doctor"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you are using any other hydrocortisone product"
      ],
      "stop_use": [
        "Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children if ingested, contact a poison control center right away."
      ],
      "dosage_and_administration": [
        "Directions apply to affected area not more than 3 to 4 times daily children under 2 years, do not use; ask a doctor"
      ],
      "storage_and_handling": [
        "Other information protect from Excessive Heat: (40℃/104℉)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aqua, Paraffinum Liquidum, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-25, Beeswax, Glycerin, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA, BHT."
      ],
      "package_label_principal_display_panel": [
        "82953-020"
      ],
      "set_id": "1b9e2d4c-bc0c-6ed0-e063-6294a90a9103",
      "id": "2005cb8c-ab0b-9d4e-e063-6294a90a861b",
      "effective_time": "20240819",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Insect sting relief latex 01"
        ],
        "generic_name": [
          "SODIUM BICARBONATE"
        ],
        "manufacturer_name": [
          "Cosmuses Cosmetics (Ningbo) Co., Ltd."
        ],
        "product_ndc": [
          "82953-020"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SODIUM BICARBONATE"
        ],
        "spl_id": [
          "2005cb8c-ab0b-9d4e-e063-6294a90a861b"
        ],
        "spl_set_id": [
          "1b9e2d4c-bc0c-6ed0-e063-6294a90a9103"
        ],
        "package_ndc": [
          "82953-020-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8MDF5V39QO"
        ]
      }
    }
  ]
}