{
  "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": [
        "Medline zinc oxide CAPRYLIC/CAPRIC TRIGLYCERIDE .ALPHA.-TOCOPHEROL ACETATE ALLANTOIN APHANIZOMENON FLOSAQUAE CETYL ALCOHOL 1,3,3,3-TETRAFLUOROPROPENE, (1Z)- CLOVE OMEGA-3 FATTY ACIDS PROPANEDIOL PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLENE GLYCOL YEAST GLYCERIN MAGNESIUM SULFATE DIMETHICONE DICAPRYLYL CARBONATE SORBITAN SESQUIOLEATE ETHYLHEXYLGLYCERIN HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) HYPNEA MUSCIFORMIS DIISOPROPYL ADIPATE WATER ZEA MAYS (CORN) OIL POLYHYDROXYSTEARIC ACID (2300 MW) DEHYDROXANTHAN GUM CAMELLIA SINENSIS LEAF ZINC OXIDE ZINC OXIDE 7-DEHYDROCHOLESTEROL ASTROCARYUM MURUMURU SEED BUTTER PEG-30 DIPOLYHYDROXYSTEARATE ZEOLITE A KUKUI NUT OIL GELIDIELLA ACEROSA PHENOXYETHANOL POLYAMIDE-8 (4500 MW) POLYGLYCERYL-3 DIISOSTEARATE"
      ],
      "active_ingredient": [
        "Active ingredient Zinc oxide 25% w/w"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness"
      ],
      "warnings": [
        "Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F."
      ],
      "do_not_use": [
        "Do not use on deep or puncture wounds animal bites serious burns"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor condition worsens symptoms last for more than 7 days or clear up and occur again within a few days"
      ],
      "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."
      ],
      "other_safety_information": [
        "Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F."
      ],
      "dosage_and_administration": [
        "Directions shake well before using for skin protection apply as needed for diaper rash change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged"
      ],
      "storage_and_handling": [
        "Other information Protect from freezing, avoid excessive heat Nonflammable"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aleurites moluccanus (kukui) seed oil, allantoin, aphanizomenon flos aquae extract, astrocaryum murumuru seed butter, butylene glycol, camellia sinensis (green tea) leaf extract, caprylic/capric triglyceride, cetyl alcohol, 7-dehydrocholesterol, dehydroxanthan gum, dicaprylyl carbonate, diisopropyl adipate, dimethicone, ethylhexylglycerin, eugenia caryophyllus (clove) flower extract, gelidiella acerosa (algae) extract, glycerin, hydrolyzed soy protein, hypnea musciformis (algae) extract, magnesium sulfate, PEG-30 dipolyhydroxystearate, phenoxyethanol, phospholipids, polyamide-8, polyglyceryl-3 diisostearate, polyhydroxystearic acid, propanediol, propylene glycol dicaprylate/dicaprate, sorbitan sesquioleate, tetrafluoropropene, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zeolite"
      ],
      "spl_unclassified_section": [
        "Manufacturing information www.medline.com ©2023 Medline and Medline Remedy are registered trademarks of Medline Industries, LP. Made in the USA of foreign and domestic materials. Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA. 1-800-MEDLINE"
      ],
      "package_label_principal_display_panel": [
        "Package Label label"
      ],
      "set_id": "dae45414-7401-9536-e053-2a95a90a0a86",
      "id": "41349255-e0cd-8d71-e063-6394a90a32ca",
      "effective_time": "20251015",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Medline"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-768"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "865073"
        ],
        "spl_id": [
          "41349255-e0cd-8d71-e063-6394a90a32ca"
        ],
        "spl_set_id": [
          "dae45414-7401-9536-e053-2a95a90a0a86"
        ],
        "package_ndc": [
          "53329-768-55"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}