{
  "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": [
        "itch relief diphenhydramine hydrochloride and zinc acetate WATER ZINC ACETATE ZINC CATION CARBOMER HOMOPOLYMER TYPE C CETYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE LIGHT MINERAL OIL METHYLPARABEN POLYSORBATE 60 PROPYLPARABEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE STEARIC ACID"
      ],
      "active_ingredient": [
        "Active ingredient Diphenhydramine Hydrochloride 2% Zinc Acetate 0.1%"
      ],
      "purpose": [
        "Purpose Topical Analgesic Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses ■ dries the oozing and weeping of poison ivy, poison oak, and poison sumac ■ temporarily relieves pain and itching associated with: ■ minor cuts ■ sunburn ■ scrapes ■ minor skin irritations ■ minor burns ■ insect bites ■ rashes due to poison ivy, poison oak and poison sumac"
      ],
      "warnings": [
        "Warnings For external use only. Do not use ■ with any other product containing diphenhydramine, even one taken by mouth ■ on large areas of the body ■ on broken, blistered, or oozing skin"
      ],
      "ask_doctor": [
        "Ask a doctor before use ■ on measles ■ on chicken pox ■ on poison ivy ■ on sunburn"
      ],
      "when_using": [
        "When using this product avoid contact with the eyes."
      ],
      "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"
      ],
      "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 ■ children under 2 years of age: ask a doctor ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ do not use more than directed"
      ],
      "storage_and_handling": [
        "Other information ■ Store at 15° to 30°C (59° to 86°F) ■ Close the cap tightly after use ■ Lot No. & Exp. Date: See box or crimp of tube"
      ],
      "inactive_ingredient": [
        "Inactive ingredients carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60, propylparaben, purified water, stearic acid"
      ],
      "spl_unclassified_section": [
        "READ AND KEEP CARTON FOR COMPLETE INFORMATION *This product is not manufactured or distributed by the owners of Benadryl® Extra Strength ItchStopping Cream. Manufactured for: Bionpharma Inc., Princeton, NJ 08540 MADE IN INDIA GUJ/DRUGS/G/25/2134 L0000814 R0424 LOT & EXP."
      ],
      "package_label_principal_display_panel": [
        "tube carton * compare to the active ingredient in Benadryl® Extra Strength Itch Stopping Cream NDC 69452-449-37 a+ health TM itch relief cream diphenhydramine HCl 2 % + zinc acetate 0.1% net wt. 1.25 oz dye-free • phthalate-free • fragrance-free • extra strength • topical analgesic • skin protectant image001"
      ],
      "set_id": "178ed513-4f22-8f11-e063-6294a90a109b",
      "id": "178ed513-4f23-8f11-e063-6294a90a109b",
      "effective_time": "20240716",
      "version": "1",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "itch relief"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE"
        ],
        "manufacturer_name": [
          "Bionpharma Inc."
        ],
        "product_ndc": [
          "69452-449"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC ACETATE",
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1087026"
        ],
        "spl_id": [
          "178ed513-4f23-8f11-e063-6294a90a109b"
        ],
        "spl_set_id": [
          "178ed513-4f22-8f11-e063-6294a90a109b"
        ],
        "package_ndc": [
          "69452-449-37"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "FM5526K07A",
          "TC2D6JAD40"
        ]
      }
    }
  ]
}