{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Anti-Itch Cream Diphenhydramine hydrochloride 2%, zinc acetate 0.1% DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE LAURETH-23 WATER CETOSTEARYL ALCOHOL PETROLATUM ZINC ACETATE ZINC CATION MINERAL OIL STEARYL ALCOHOL METHYLPARABEN PROPYLENE GLYCOL STEARIC ACID GLYCERYL MONOSTEARATE PROPYLPARABEN"
      ],
      "active_ingredient": [
        "Active Ingredient Diphenhydramine Hydrochloride 2%",
        "Active Ingredient Zinc Acetate 0.1%"
      ],
      "purpose": [
        "Purpose Topical Analgesic",
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "For the temporary relief from pain and itching associated with insect bites minor burns minor skin irritation rashes due to poison ivy, poison oak, and poison sumac dries the weeping and oozing of poison ivy, oak and sumac"
      ],
      "warnings": [
        "Warnings For External Use Only Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox or measles When using this product avoid contact with eyes Stop use and ask a doctor if Conditions worsen or do not improve within 7 days Symptoms persist for more than 7 days or clear up and occur again within a few days"
      ],
      "stop_use": [
        "Stop use and ask a doctor Conditions worsen or do not improve within 7 days Symptoms persist for more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center immediately"
      ],
      "dosage_and_administration": [
        "Directions Do not use more than directed Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a doctor"
      ],
      "storage_and_handling": [
        "Other information Store at controlled room temperature 20º-25ºC (68º-77ºF) Close cap tightly after use Questions? Call 1-888-296-9067"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid"
      ],
      "spl_unclassified_section": [
        "Distributed By: Trifecta Pharmaceuticals USA, LLC. 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA Product of PRC www.trifecta-pharma.com"
      ],
      "package_label_principal_display_panel": [
        "Packaging Globe Anti-itch Cream 1.5oz Rev10 062422 CDER"
      ],
      "set_id": "44d17651-a31b-64ca-e054-00144ff8d46c",
      "id": "0df7f83e-5adb-ec48-e063-6294a90a198e",
      "effective_time": "20240102",
      "version": "5",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Anti-Itch Cream"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%"
        ],
        "manufacturer_name": [
          "Trifecta Pharmaceuticals USA, LLC."
        ],
        "product_ndc": [
          "69396-025"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1087026"
        ],
        "spl_id": [
          "0df7f83e-5adb-ec48-e063-6294a90a198e"
        ],
        "spl_set_id": [
          "44d17651-a31b-64ca-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "69396-025-05",
          "69396-025-15"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0860001004984"
        ],
        "unii": [
          "TC2D6JAD40",
          "FM5526K07A"
        ]
      }
    }
  ]
}