{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Dandruff Pyrithione Zinc WATER SODIUM CHLORIDE ZINC CARBONATE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 GLYCOL DISTEARATE D&C RED NO. 33 SODIUM XYLENESULFONATE COCAMIDOPROPYL BETAINE METHYLCHLOROISOTHIAZOLINONE CITRIC ACID MONOHYDRATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) AMODIMETHICONE (800 CST) SODIUM BENZOATE PYRITHIONE ZINC PYRITHIONE ZINC MAGNESIUM CARBONATE HYDROXIDE SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE"
      ],
      "spl_unclassified_section": [
        "Claims Multiple benefit formula to help: Fight dry scalp Reduce oiliness Calm itch Prevent flakes Relieve irritation Leave hair healthy looking Soothe and reduce redness",
        "Disclaimer *This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders ® Classic Clean Dandruff Shampoo."
      ],
      "active_ingredient": [
        "Active ingredient Pyrithione zinc 1%"
      ],
      "purpose": [
        "Purpose Anti-dandruff"
      ],
      "indications_and_usage": [
        "Use helps prevent recurrence of flaking and itching associated with dandruff"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product do not get into 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 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."
      ],
      "dosage_and_administration": [
        "Directions shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33"
      ],
      "adverse_reactions": [
        "Adverse Reaction Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel SIMPLY U ® DANDRUFF SHAMPOO PYRITHIONE ZINC EVERYDAY CLEAN Helps relieve scalp dryness, itch and irritaion Gentle and pH balanced for everyday use Compare to Head & Shoulders ® Classic Clean Dandruff Shampoo* 12.5 FL OZ (370 mL) mm01 mm02"
      ],
      "set_id": "3c55b70f-7627-8667-e063-6394a90a5cf8",
      "id": "4cd63c29-0bf3-9973-e063-6294a90af2fb",
      "effective_time": "20260312",
      "version": "2",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Dandruff"
        ],
        "generic_name": [
          "PYRITHIONE ZINC"
        ],
        "manufacturer_name": [
          "Nice-Pak Products, LLC"
        ],
        "product_ndc": [
          "11344-153"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "209884"
        ],
        "spl_id": [
          "4cd63c29-0bf3-9973-e063-6294a90af2fb"
        ],
        "spl_set_id": [
          "3c55b70f-7627-8667-e063-6394a90a5cf8"
        ],
        "package_ndc": [
          "11344-153-32"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}