{
  "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": [
        "Baza Protect Zinc oxide and Dimethicone ZINC OXIDE ZINC OXIDE DIMETHICONE, UNSPECIFIED DIMETHICONE, UNSPECIFIED CETYL ALCOHOL GLYCERYL MONOSTEARATE TRICONTANYL POVIDONE PETROLATUM LANOLIN PEG-8 MONOSTEARATE PROPYLENE GLYCOL PEG-40 MONOSTEARATE EDETIC ACID COD LIVER OIL .ALPHA.-TOCOPHEROL ACETATE, D- BUTYLATED HYDROXYTOLUENE QUATERNIUM-15 WATER"
      ],
      "spl_unclassified_section": [
        "For Skin Irritation Due to Incontinence Protects Easy to apply and remove Seals out wetness",
        "Drug Facts Active ingredients Zinc Oxide, 12% Dimethicone, 1 % Purpose Diaper Rash Skin Protectant Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness. Warnings When using this product avoid contact with eyes not to be applied over deep or puncture wounds or lacerations. Consult a doctor if condition worsens or does not improve within 7 days. For external use only. Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions change wet and soiled diapers promptly apply to affected area and gently wipe with clean, soft cloth apply as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged. Inactive ingredients BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water See crimp for lot no. and expiration date Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A. 1-800-533-0464 www.us.cobplast.com Product #1880 ©2008-7, Coloplast Corp. Made in the U.S.A. G8-773"
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide, 12% Dimethicone, 1 %"
      ],
      "purpose": [
        "Purpose Diaper Rash Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps seal out wetness."
      ],
      "warnings": [
        "Warnings"
      ],
      "when_using": [
        "When using this product avoid contact with eyes not to be applied over deep or puncture wounds or lacerations."
      ],
      "ask_doctor": [
        "Consult a doctor if condition worsens or does not improve within 7 days."
      ],
      "keep_out_of_reach_of_children": [
        "Keep this and all drugs out of the 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 apply to affected area and gently wipe with clean, soft cloth apply as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged."
      ],
      "inactive_ingredient": [
        "Inactive ingredients BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water See crimp for lot no. and expiration date Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A. 1-800-533-0464 www.us.cobplast.com Product #1880 ©2008-7, Coloplast Corp. Made in the U.S.A. G8-773"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g) NDC 11701-046-14 Baza ® Protect Skin Protectant Moisture Barrier Cream For Skin Irritation Due to Incontinence Coloplast NET WT. 5 OZ. (142 g) PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)"
      ],
      "set_id": "ed63df26-3879-46df-8e09-10be569b25be",
      "id": "a888e9dc-9ced-4e46-9aba-6570c65ad11f",
      "effective_time": "20260331",
      "version": "10",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Baza Protect"
        ],
        "generic_name": [
          "ZINC OXIDE AND DIMETHICONE"
        ],
        "manufacturer_name": [
          "Coloplast Corp"
        ],
        "product_ndc": [
          "11701-046"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "DIMETHICONE, UNSPECIFIED"
        ],
        "rxcui": [
          "637565",
          "1053158"
        ],
        "spl_id": [
          "a888e9dc-9ced-4e46-9aba-6570c65ad11f"
        ],
        "spl_set_id": [
          "ed63df26-3879-46df-8e09-10be569b25be"
        ],
        "package_ndc": [
          "11701-046-22",
          "11701-046-23",
          "11701-046-14"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}