{
  "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": [
        "Vanicream Pyrithione Zinc 1,2-HEXANEDIOL METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) SUCROSE COCOATE SUCROSE STEARATE CAPRYLYL GLYCOL COCO GLUCOSIDE SODIUM COCOYL GLYCINATE WATER DOCOSANOL PENTYLENE GLYCOL GLYCERIN DEXPANTHENOL LAURYL GLUCOSIDE DISODIUM COCOYL GLUTAMATE CETYL PALMITATE SODIUM COCOYL GLUTAMATE SODIUM HYDROXIDE SODIUM CHLORIDE PYRITHIONE ZINC PYRITHIONE ZINC"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by PHARMACEUTICAL SPECIALTIES, INC. ROCHESTER, MN 55901 1-800-325-8232 Made in USA with select US and imported materials"
      ],
      "active_ingredient": [
        "Active Ingredient Pyrithione zinc 2%"
      ],
      "purpose": [
        "Purposes Anti-dandruff, Anti-seborrheic dermatitis"
      ],
      "indications_and_usage": [
        "Uses Controls and reduces the symptoms of dandruff and seborrheic dermatitis"
      ],
      "warnings": [
        "Warnings For external use only Ask a doctor before use if you have a condition that covers a large area of the body. 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."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have a condition that covers a large area of the body."
      ],
      "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."
      ],
      "dosage_and_administration": [
        "Directions For best results use at least twice a week or as directed by a doctor Shake before use Wet hair and massage gently into scalp Leave lather on scalp for several minutes Rinse well, repeat if needed"
      ],
      "storage_and_handling": [
        "Other information Store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, lauryl glucoside, coco-glucoside, acrylates copolymer, panthenol, pentylene glycol, glycerin, sucrose cocoate, disodium cocoyl glutamate, sodium cocoyl glycinate, behenyl alcohol, sucrose stearate, cetyl palmitate, sodium cocoyl glutamate, 1,2-hexanediol, sodium hydroxide, caprylyl glycol, sodium chloride"
      ],
      "questions": [
        "Questions? 1-800-325-8232 www.vanicream.com"
      ],
      "package_label_principal_display_panel": [
        "NDC 45334-206-08 VANICREAM™ Pyrithione Zinc 2% Dandruff Shampoo for Sensitive Skin DERMATOLOGIST TESTED Free of dyes, fragrance, masking fragrance, lanolin, protein, parabens, & formaldehyde releasers Sulfate-free • Betaine-free • Gluten-free 8 fl oz (237 mL) label"
      ],
      "set_id": "d124a093-f739-0666-e053-2995a90a52ed",
      "id": "27eab869-7131-aed3-e063-6394a90adcb3",
      "effective_time": "20241127",
      "version": "3",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Vanicream"
        ],
        "generic_name": [
          "PYRITHIONE ZINC"
        ],
        "manufacturer_name": [
          "Pharmaceutical Specialties, Inc."
        ],
        "product_ndc": [
          "45334-206"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PYRITHIONE ZINC"
        ],
        "rxcui": [
          "244458"
        ],
        "spl_id": [
          "27eab869-7131-aed3-e063-6394a90adcb3"
        ],
        "spl_set_id": [
          "d124a093-f739-0666-e053-2995a90a52ed"
        ],
        "package_ndc": [
          "45334-206-08",
          "45334-206-07"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R953O2RHZ5"
        ]
      }
    }
  ]
}