{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Pyrithione zinc Pyrithione zinc WATER SODIUM LAURYL SULFATE SODIUM LAURETH SULFATE GLYCOL DISTEARATE SODIUM CHLORIDE ZINC CARBONATE SODIUM XYLENESULFONATE AMODIMETHICONE (800 CST) COCAMIDOPROPYL BETAINE SODIUM BENZOATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE PEPPERMINT OIL MENTHA ARVENSIS LEAF OIL TEA TREE OIL CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE HYDROXYCITRONELLAL LINALOOL, (+/-)- FD&C BLUE NO. 1 FD&C YELLOW NO. 5 PYRITHIONE ZINC PYRITHIONE ZINC"
      ],
      "spl_unclassified_section": [
        "claims Multiple Benefit formula to help: Fight dry scalp Calm itch Relieve irritation Soothe and reduce redness Reduce oiliness Prevent flakes Leave hair healthy looking",
        "Disclaimer *This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders ® Tea Tree Oil 2in1 Dandruff Shampoo + Conditioner."
      ],
      "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 controll, 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, Mentha piperita (peppermint) oil, Mentha arvensis leaf oil, Melaleuca alternifolia (tea tree) leaf oil, citric acid, methylchloroisothiazolinone, methylisothiazolinone, hydroxycitronellal, linalool, blue 1, yellow 5"
      ],
      "adverse_reactions": [
        "Adverse Reactions 100% Satisfaction Guaranteed! (888)309-9030 DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel STUDIO SELECTION ® TEA TREE DANDRUFF SHAMPOO + CONDITIONER PYRITHIONE ZINC 1% Compare to Head & Shoulders ® Tea Tree Oil 2 in 1 Dandruff Shampoo & Conditioner* Cooling relief from scalp itch Paraben free 2in1 Paraben + Phthalate Free 12.5 FL OZ (370 mL) image description image description"
      ],
      "set_id": "f17154e2-1bcf-43f9-b201-e84d374a0591",
      "id": "4c0fa07b-b80f-095d-e063-6394a90a8d88",
      "effective_time": "20260302",
      "version": "4",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Pyrithione zinc"
        ],
        "generic_name": [
          "PYRITHIONE ZINC"
        ],
        "manufacturer_name": [
          "Old East Main Co."
        ],
        "product_ndc": [
          "75712-470"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "209884"
        ],
        "spl_id": [
          "4c0fa07b-b80f-095d-e063-6394a90a8d88"
        ],
        "spl_set_id": [
          "f17154e2-1bcf-43f9-b201-e84d374a0591"
        ],
        "package_ndc": [
          "75712-470-32"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}