{
  "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",
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  "results": [
    {
      "spl_product_data_elements": [
        "Control Dandruff Therapy dandruff therapy shampoo PYRITHIONE ZINC PYRITHIONE ZINC AMMONIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE SALICYLIC ACID SODIUM CHLORIDE SAPINDUS MUKOROSSI FRUIT SODIUM BENZOATE SODIUM LAUROYL SARCOSINATE WATER TROLAMINE AMMONIUM LAURETH-2 SULFATE POLYQUATERNIUM-10 (10000 MPA.S AT 2%)"
      ],
      "spl_unclassified_section": [
        "Drug Facts Active ingredient Pyrithione Zinc 1.0% Purpose Anti-Dandruff Use helps eliminate flaking, itching and scaling associated with dandruff and seborrheic dermatitis Warnings For external use only When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away. If condition covers a large area of the body, consult your doctor before using this product. Directions adults and children 3 years of age and older: apply to wet hair gently massage into hair and scalp and leave for 2-3 minutes before thoroughly rinsing rinse and repeat if desired for best results use at least twice a week or as directed by your doctor Inactive ingredients ammonium laureth sulfate, water, ammonium lauryl sulfate, cocamidopropyl betaine, sodium lauroyl sarcosinate, soapberry ( Sapindus mukurossi ) fruit extract, salicylic acid, salt (sodium chloride), polyquaternium-10, sodium benzoate, triethanolamine, fragrance",
        "Made in USA (US and non US ingredients) Manufactured for Kamedis Pennsylvania, 18109. www.kamedis.com"
      ],
      "active_ingredient": [
        "Active ingredient Pyrithione Zinc 1.0%"
      ],
      "purpose": [
        "Purpose Anti-Dandruff"
      ],
      "indications_and_usage": [
        "Use helps eliminate flaking, itching and scaling associated with dandruff and seborrheic dermatitis"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed"
      ],
      "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. If condition covers a large area of the body, consult your doctor before using this product."
      ],
      "dosage_and_administration": [
        "Directions adults and children 3 years of age and older: apply to wet hair gently massage into hair and scalp and leave for 2-3 minutes before thoroughly rinsing rinse and repeat if desired for best results use at least twice a week or as directed by your doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients ammonium laureth sulfate, water, ammonium lauryl sulfate, cocamidopropyl betaine, sodium lauroyl sarcosinate, soapberry ( Sapindus mukurossi ) fruit extract, salicylic acid, salt (sodium chloride), polyquaternium-10, sodium benzoate, triethanolamine, fragrance"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton Kamedis ® Skin Restoring Solutions BOTANIPLEX TECHNOLOGY SCALP CONTROL Dandruff Therapy Shampoo PYRITHIONE ZINC 1% Clinically proven to remove up to 100% visible dandruff. Helps eliminate flaking, scaling, itching, irritation and redness associated with dandruff DERMATOLOGIST RECOMMENDED Free from Parabens, Steroids, Dyes, Sodium Lauryl Sulfate, Tar 200 mL 6.7 fl oz PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton"
      ],
      "set_id": "2a5fc8ae-1d98-496c-a6ca-922897e3ab47",
      "id": "6820d2bc-1aaf-4bca-ae9a-d1509d8f4232",
      "effective_time": "20231218",
      "version": "5",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Control Dandruff Therapy"
        ],
        "generic_name": [
          "DANDRUFF THERAPY SHAMPOO"
        ],
        "manufacturer_name": [
          "Kamedis"
        ],
        "product_ndc": [
          "50718-0021"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "209884"
        ],
        "spl_id": [
          "6820d2bc-1aaf-4bca-ae9a-d1509d8f4232"
        ],
        "spl_set_id": [
          "2a5fc8ae-1d98-496c-a6ca-922897e3ab47"
        ],
        "package_ndc": [
          "50718-0021-1",
          "50718-0021-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}