{
  "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": [
        "AmeriDerm PeriShield ZINC OXIDE FD&C YELLOW NO. 5 GLYCERYL MONOSTEARATE ALOE VERA LEAF CHLOROXYLENOL CHOLECALCIFEROL CORN OIL LANOLIN MINERAL OIL PARAFFIN PHENOXYETHANOL VITAMIN A PALMITATE SODIUM BORATE ALPHA-TOCOPHEROL ZINC OXIDE ZINC OXIDE ETHYLHEXYLGLYCERIN SODIUM LAURETH-3 SULFATE STEARIC ACID GLYCERIN CETOSTEARYL ALCOHOL MICROCRYSTALLINE WAX ISOPROPYL MYRISTATE WATER FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID"
      ],
      "active_ingredient": [
        "Active Ingredient Zinc Oxide 3.8%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses ■ Helps treat and prevent rash associated with diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash and ■ Helps protect skin from exposure to wetness"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product ■ Avoid contact with eyes ■ If eye contact, occurs, flush with water"
      ],
      "stop_use": [
        "Stop Use and ask a doctor if ■ condition worsens or doesn't improve within seven 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."
      ],
      "dosage_and_administration": [
        "Directions ■ Change wet and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aloe Barbadensis Gel, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol, Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin A Palmitate, Water"
      ],
      "package_label_principal_display_panel": [
        "Package Label Principal Display and Drug Fact Panel"
      ],
      "set_id": "417f1541-d65a-4612-b96b-e6183fbef1f3",
      "id": "3c6a8249-6365-a555-e063-6294a90a1ecc",
      "effective_time": "20250815",
      "version": "17",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "AmeriDerm PeriShield"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Shield Line LLC"
        ],
        "product_ndc": [
          "52410-8020"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1089065"
        ],
        "spl_id": [
          "3c6a8249-6365-a555-e063-6294a90a1ecc"
        ],
        "spl_set_id": [
          "417f1541-d65a-4612-b96b-e6183fbef1f3"
        ],
        "package_ndc": [
          "52410-8020-4",
          "52410-8020-0"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0352410802003"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}