{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "DERMEDIAL Anti-Itch Oatmeal, zinc oxide HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX MELALEUCA ERICIFOLIA LEAF OIL OLEA EUROPAEA (OLIVE) FRUIT OIL POGOSTEMON CABLIN LEAF OIL JUNIPERUS VIRGINIANA WOOD OIL TEA TREE OIL LAVENDER OIL BLACK PEPPER OIL PELARGONIUM GRAVEOLENS FLOWER OIL ZINC OXIDE ZINC OXIDE OATMEAL OATMEAL"
      ],
      "active_ingredient": [
        "Colloidal oatmeal 10.67% Zinc oxide 3.20%"
      ],
      "purpose": [
        "Skin protectant ointment"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites"
      ],
      "warnings": [
        "For external use only. When using this produc t, avoid contact with the eyes. If condition worsens or does not improve within 7 days, consult a doctor. Keep out of reach of children. Avoid contact with the eyes. If condition worsens or does not improve within 7 days, consult a doctor. Keep out of reach of children."
      ],
      "when_using": [
        "Avoid contact with the eyes."
      ],
      "ask_doctor": [
        "If condition worsens or does not improve within 7 days, consult a doctor."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Adults and children 2 years and older: Apply to affected area as needed."
      ],
      "inactive_ingredient": [
        "helianthus annuus (sunflower) seed wax, juniperus virginiana (virginiana cedar) wood oil, lavandula angustifolia (lavender) oil, melaleuca alternifolia (tea tree) leaf oil, melaleuca ericifolia (rosalina) leaf oil, olea europaea (olive) fruit oil, pelargonium graveolens (rose geranium) flower oil, piper nigrum (pepper) fruit oil, pogostemon cablin (patchouli) leaf oil."
      ],
      "other_safety_information": [
        "Important: For each product, read all product information on outer and inner box flap before using. Keep this package for full information. Do not use if security seal is broken or missing."
      ],
      "description": [
        "Dermedial Anti-Itch+ calming oat stick"
      ],
      "questions": [
        "Distributed by: Saje Natural Wellness 101-19347 24th Ave Surrey, BC V3S 3S9 | saje.com | @sajewellness | Questions? call 1-877-275-7253 | Made in Canada | Please recycle where possible | SKU 713803"
      ],
      "package_label_principal_display_panel": [
        "Dermedial Anti-Itch+ - Outer Label Anti-itch + outer box Dermedial Anti-itch outer label",
        "topical balm 0.45 oz | 13 g"
      ],
      "set_id": "385dd757-740b-8324-e063-6294a90afeee",
      "id": "484ffee4-8995-81ae-e063-6294a90a731d",
      "effective_time": "20260113",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "DERMEDIAL Anti-Itch"
        ],
        "generic_name": [
          "OATMEAL, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Saje Natural Business Inc"
        ],
        "product_ndc": [
          "70983-029"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "OATMEAL"
        ],
        "spl_id": [
          "484ffee4-8995-81ae-e063-6294a90a731d"
        ],
        "spl_set_id": [
          "385dd757-740b-8324-e063-6294a90afeee"
        ],
        "package_ndc": [
          "70983-029-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "SOI2LOH54Z",
          "8PI54V663Y"
        ]
      }
    }
  ]
}