{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "OKeeffes Working Hands Pain Relief Skin Protectant allantoin, lidocaine hydrochloride 1,2-HEXANEDIOL ETHYLHEXYLGLYCERIN ISOPROPYL MYRISTATE GLYCERYL 1-STEARATE PEPPERMINT OIL SHEA BUTTER ALUMINUM STARCH OCTENYLSUCCINATE POLYOXYL 20 CETOSTEARYL ETHER LAURETH-12 CAPRYLYL GLYCOL CETOSTEARYL ALCOHOL DODECAMETHYLPENTASILOXANE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SODIUM HYDROXIDE ALLANTOIN ALLANTOIN CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETATE DISODIUM ANHYDROUS GLYCERIN PEG-100 STEARATE CETYL ALCOHOL PHENOXYETHANOL XANTHAN GUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS WHITE WAX WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "O'KEEFFE'S ® WORKING HANDS ® PAIN RELIEF CREAM SKIN PROTECTANT PAIN RELIEF RELIEVES, SOOTHES & HYDRATES INSTANT RELIEF from: Pain Itching Irritation Dryness 2 IN 1 PAIN RELIEF & MOISTURIZER MAX STRENGTH † 4% LIDOCAINE COOLING PEPPERMINT OIL CLINICALLY PROVEN RELIEVES SOOTHES HYDRATES PROTECTS"
      ],
      "active_ingredient": [
        "Active ingredients . . . . . . . . . . . . . Purposes Allantoin 0.5% . . . . . . . . . . . . . . . . Skin protectant Lidocaine HCl 4% . . . . . . . . . . . . . Topical analgesic"
      ],
      "purpose": [
        "Purposes"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves pain and itching associated with minor skin irritations protects and helps relieve chapped or cracked skin"
      ],
      "warnings": [
        "Warnings For external use only Do not use in large quantities, particularly over raw surfaces or blistered areas. on deep or puncture wounds, animal bites or serious burns When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use in large quantities, particularly over raw surfaces or blistered areas. on deep or puncture wounds, animal bites or serious burns"
      ],
      "when_using": [
        "When using this product avoid contact with eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding , ask a health professional before use."
      ],
      "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 adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. children under 12 years of age: consult a doctor."
      ],
      "other_safety_information": [
        "Other information Child-resistant packaging. Store with lid closed tightly."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Starch Octenylsuccinate, Beeswax, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, 1,2 Hexanediol, Isopropyl Myristate, Laureth-12, PEG-100 Stearate, Peppermint (Mentha Piperita) Oil, Phenoxyethanol, Polysilicone-11, Shea (Butyrospermum Parkii) Butter, Sodium Hydroxide, Water, Xanthan Gum"
      ],
      "questions": [
        "Questions or comments? 1-800-275-2718"
      ],
      "package_label_principal_display_panel": [
        "OKEEFFE'S ® WORKING HANDS ® PAIN RELIEF CREAM SKIN PROTECTANT Net Wt. 3 oz (85 g) OKeeffesCompany.com 1-800-275-2718 ©2023 Distributed by: O'Keeffe's Company Cincinnati, OH 45241 Made in USA with Domestic and Imported Materials label"
      ],
      "set_id": "0685da25-c9fa-e1cd-e063-6394a90ae1b3",
      "id": "2cca0907-5d70-e478-e063-6294a90ad19d",
      "effective_time": "20250101",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "OKeeffes Working Hands Pain Relief Skin Protectant"
        ],
        "generic_name": [
          "ALLANTOIN, LIDOCAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "The Gorilla Glue Company/O'Keeffe's Company"
        ],
        "product_ndc": [
          "71564-009"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ALLANTOIN",
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "2594492"
        ],
        "spl_id": [
          "2cca0907-5d70-e478-e063-6294a90ad19d"
        ],
        "spl_set_id": [
          "0685da25-c9fa-e1cd-e063-6394a90ae1b3"
        ],
        "package_ndc": [
          "71564-009-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0371564000660"
        ],
        "unii": [
          "344S277G0Z",
          "V13007Z41A"
        ]
      }
    }
  ]
}