{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Renew Periprotect Skin Protectant ZINC OXIDE ZINC OXIDE DIMETHICONE DIMETHICONE PETROLATUM 2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL VITAMIN A PALMITATE TOCOPHERYL RETINOATE WATER N-(1,3,4-TRIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA MINERAL OIL PARAFFIN CHOLECALCIFEROL ALOE VERA LEAF POLYSACCHARIDES ALUMINUM STEARATE YELLOW WAX CORN OIL PHENOXYETHANOL PROPYLPARABEN SORBITAN SESQUIOLEATE METHYLPARABEN CHLOROXYLENOL LANOLIN"
      ],
      "active_ingredient": [
        "​Active Ingredients: Zinc Oxide 12% Dimethicone 1%"
      ],
      "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, Avoid contact with eyes , In case of contact, flush thoroughly with water."
      ],
      "ask_doctor": [
        "Warnings: Stop use and ask a doctor If • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days."
      ],
      "keep_out_of_reach_of_children": [
        "Warnings: Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions: Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged."
      ],
      "other_safety_information": [
        "Other Information: Store at room temperature (59º-86ºF) You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients : Aloe Barbadensis Leaf Juice, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Imidazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin Wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water."
      ],
      "questions": [
        "Questions? Call 800-337-6296 Mon - Fri 9AM - 5PM EST."
      ],
      "package_label_principal_display_panel": [
        "Renew Periprotect Package Label Principal Display Panel Case Label Package Label and Principal Display Panel"
      ],
      "set_id": "5bd49bb0-03a7-562c-e053-2a91aa0a19d8",
      "id": "288807b6-3f77-910e-e063-6394a90ac04d",
      "effective_time": "20241205",
      "version": "4",
      "openfda": {}
    }
  ]
}