{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Itch Relief Cream Zinc Acetate 0.1%, Diphenhydramine hydrochloride 2% METHYLPARABEN GLYCERYL MONOSTEARATE PETROLATUM LAURETH-23 WATER MINERAL OIL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PROPYLPARABEN STEARYL ALCOHOL PROPYLENE GLYCOL STEARIC ACID ZINC ACETATE ZINC CATION CETOSTEARYL ALCOHOL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Itch Relief Cream Antihistamine Topical Analgesic Skin Protectant Temporarily relieves the itching and pain associated with: insect bites allergic itch skin irritations",
        "Distributed By: Pharmacy Value Alliance, LLC. 407 East Lancaster Avenue Wayne, PA. 19087 www.emersongroup.com Product of PRC"
      ],
      "active_ingredient": [
        "Active Ingredient Diphenhydramine Hydrochloride 2%",
        "Active Ingredient Zinc Acetate 0.1%"
      ],
      "purpose": [
        "Purpose Topical Analgesic",
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses For the temporary relief from pain and itcing assciated with: insect bites minor burns sunburn minor skin irritation minor cuts rashes due to poison ivy, poison oak, and poison sumac dries 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 if you have chicken pox or measles When using this product avoid contact with eyes."
      ],
      "stop_use": [
        "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"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children. If swallowed, get medical help or contact 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 20°-25°C (68°-77°F) Close cap tightly after use"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aloe Vera (Aloe Barbadensis), leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Pil, Petrolatum, Polyoxyethylene, lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid"
      ],
      "package_label_principal_display_panel": [
        "Packaging Itch Relief Cream"
      ],
      "set_id": "37fe6d82-adee-4f58-e054-00144ff88e88",
      "id": "29b74830-5473-c90b-e063-6294a90a4e72",
      "effective_time": "20241220",
      "version": "8",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Itch Relief Cream"
        ],
        "generic_name": [
          "ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%"
        ],
        "manufacturer_name": [
          "Pharmacy Value Alliance LLC"
        ],
        "product_ndc": [
          "68016-163"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1087026"
        ],
        "spl_id": [
          "29b74830-5473-c90b-e063-6294a90a4e72"
        ],
        "spl_set_id": [
          "37fe6d82-adee-4f58-e054-00144ff88e88"
        ],
        "package_ndc": [
          "68016-163-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0840986012761"
        ],
        "unii": [
          "TC2D6JAD40",
          "FM5526K07A"
        ]
      }
    }
  ]
}