{
  "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,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "ItchZap Diphenhydramine Hydrochloride and Zinc Acetate DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE ZINC CATION BENZYL ALCOHOL CETYL ALCOHOL GLYCERYL MONOSTEARATE GLYCERYL STEARATE/PEG-100 STEARATE PROPYLENE GLYCOL WATER"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredients Diphenhydramine Hydrochloride 2% Zinc Acetate 0.1%"
      ],
      "purpose": [
        "Purpose Topical analgesic Skin protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac dries the oozing and weeping of poison ivy, poison oak and poison sumac"
      ],
      "warnings": [
        "Warnings For external use only. Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox on measles When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persists for more than 7 days or clear up and occur again within a few 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 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: ask a doctor"
      ],
      "other_safety_information": [
        "Other Information store between 15°C - 25°C (59°- 77°F) Lot No. & Exp Date: See box or crimp of tube"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Benzyl alcohol, cetyl alcohol, glyceryl monostearate SE, glyceryl stearate/PEG 100 stearate, propylene glycol, water"
      ],
      "questions": [
        "Questions and comments? Call 1-844-474-7464 ItchZap TM is a trademark owned by Rising Pharma Holdings, Inc. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Mfg. Lic. No.: G/25/1362"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NDC 57237-352-28 ItchZap TM Diphenhydramine Hydrochloride 2% & Zinc Acetate 0.1% Anti-Itch Cream Extra Strength Topical Analgesic/Skin Protectant diphenhydramine-zinc-acetate"
      ],
      "set_id": "245d0afb-19a8-4cfb-968b-d892b18d5f2c",
      "id": "efed5317-cd02-4fe0-8287-f5a763dd4736",
      "effective_time": "20251106",
      "version": "1",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "ItchZap"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "57237-352"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1087026"
        ],
        "spl_id": [
          "efed5317-cd02-4fe0-8287-f5a763dd4736"
        ],
        "spl_set_id": [
          "245d0afb-19a8-4cfb-968b-d892b18d5f2c"
        ],
        "package_ndc": [
          "57237-352-28"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40",
          "FM5526K07A"
        ]
      }
    }
  ]
}