{
  "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": [
    {
      "effective_time": "20120605",
      "inactive_ingredient": [
        "Inactive ingredients cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water"
      ],
      "purpose": [
        "Purpose Topical analgesic Skin protectant"
      ],
      "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."
      ],
      "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 the eyes Stop use and ask a doctor if condition worsens or does 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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product avoid contact with the eyes"
      ],
      "questions": [
        "Questions or comments? 1-800-616-2471"
      ],
      "spl_product_data_elements": [
        "Diphenhydramine Diphenhydramine Hydrochloride, Zinc Acetate DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE ZINC CETYL ALCOHOL DIAZOLIDINYL UREA METHYLPARABEN PEG-2 STEARATE PEG-20 STEARATE PROPYLENE GLYCOL PROPYLPARABEN WATER"
      ],
      "ask_doctor": [
        "Ask a doctor before use on chicken pox on measles"
      ],
      "openfda": {},
      "version": "1",
      "dosage_and_administration": [
        "Directions do not use more than directed adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily children under 2 years of age: ask a doctor"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days"
      ],
      "storage_and_handling": [
        "Other information store at 20°-25°C (68°-77°F)"
      ],
      "do_not_use": [
        "Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Diphenhydramine Hydrochloride 2% Cream 28 g NDC 54868-0113-0 Extra Strength Anti-Itch Cream Topical Analgesic/Skin Protectant Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 image of package label"
      ],
      "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"
      ],
      "set_id": "82e6a91c-fb8b-42b5-8b01-3db180b9d7fc",
      "id": "3a858a9c-77ae-4466-b31c-fff11fa7d469",
      "active_ingredient": [
        "Active ingredient Diphenhydramine hydrochloride 2% Zinc acetate 0.1%"
      ]
    }
  ]
}