{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "CalaSoothe Calamine, Menthol, and Zinc Oxide THYMOL GLYCERIN WHITE PETROLATUM MENTHOL MENTHOL ZINC OXIDE ZINC OXIDE SODIUM BICARBONATE PHENOL MINERAL OIL FERRIC OXIDE RED FERRIC OXIDE RED LANOLIN"
      ],
      "active_ingredient": [
        "Active ingredient Calamine USP 5% Menthol USP 0.44% Zinc Oxide USP 20.625%"
      ],
      "purpose": [
        "Purpose Skin Protectant Anorectal Analgesic Anorectal Astringent"
      ],
      "indications_and_usage": [
        "Uses • Dries the oozing and weeping of poison: • ivy •oak • sumac • Helps relieve the itching and discomfort associated with anorectal disorders • For the temporary relief of irritation and burning • May provide a cooling sensation"
      ],
      "warnings": [
        "Warnings For external use only Stop use and ask a doctor if • condition worsens or does not improve within 7 days, concult a doctor • bleeding occurs • redness, irritation, swelling, or pain develops or increases When using this product • Do not exceed the recommended daily dosage unless directed by a doctor • Certain people can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symtoms develop or increase, discontinue use and consult a doctor. • Do not put this product into the rectum by using fingers or any mechanical device or applicator If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "stop_use": [
        "Stop use and ask a doctor if • condition worsens or does not improve within 7 days, concult a doctor • bleeding occurs • redness, irritation, swelling, or pain develops or increases"
      ],
      "when_using": [
        "When using this product • Do not exceed the recommended daily dosage unless directed by a doctor • Certain people can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symtoms develop or increase, discontinue use and consult a doctor. • Do not put this product into the rectum by using fingers or any mechanical device or applicator"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily or after each bowel movement. • Children under 12 years of age: Consult a doctor"
      ],
      "other_safety_information": [
        "Other information • Store at room temperature 15°-30°C (59°-86°F) • Tamper Evident. Do not use if seal is damaged."
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerin, lanolin, mineral oil, phenol, sodium bicarbonate, thymol, white petrolatum"
      ],
      "questions": [
        "Questions? 1-888-DYNAREX Monday - Friday, 9AM - 5PM EST."
      ],
      "package_label_principal_display_panel": [
        "Label 1271 1271_BX_MASTER",
        "Label 1273 1273_IN_MASTER",
        "Label 1275 1275_IN_MASTER"
      ],
      "set_id": "54f12005-acfe-4821-e063-6394a90ac304",
      "id": "54f12005-acff-4821-e063-6394a90ac304",
      "effective_time": "20260624",
      "version": "1",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "CalaSoothe"
        ],
        "generic_name": [
          "CALAMINE, MENTHOL, AND ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Dynarex Corporation"
        ],
        "product_ndc": [
          "67777-241"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL",
          "ZINC OXIDE",
          "FERRIC OXIDE RED"
        ],
        "rxcui": [
          "2746895"
        ],
        "spl_id": [
          "54f12005-acff-4821-e063-6394a90ac304"
        ],
        "spl_set_id": [
          "54f12005-acfe-4821-e063-6394a90ac304"
        ],
        "package_ndc": [
          "67777-241-01",
          "67777-241-02",
          "67777-241-03",
          "67777-241-04",
          "67777-241-05",
          "67777-241-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0616784127125",
          "0616784127514",
          "0840117347939"
        ],
        "unii": [
          "L7T10EIP3A",
          "SOI2LOH54Z",
          "1K09F3G675"
        ]
      }
    }
  ]
}