{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Herklin Lice Treatment Piperonyl butoxide, Pyrethrum extract PIPERONYL BUTOXIDE PIPERONYL BUTOXIDE PYRETHRUM EXTRACT PYRETHRUM EXTRACT PEG-25 HYDROGENATED CASTOR OIL POLYQUATERNIUM-10 (125 MPA.S AT 2%) ALCOHOL WATER"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredients Piperonyl butoxide 4%.........................................................................Lice Treatment Pyrethrum extract (equivalent to 0.33 % pyrethrins.................................Lice Treatment"
      ],
      "inactive_ingredient": [
        "​Inactive Ingredients ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol"
      ],
      "purpose": [
        "Purpose Treatment head, pubic (crab), and body lice"
      ],
      "indications_and_usage": [
        "​Uses ​ ​Uses treats head lice, pubic (crab) lice, and body lice"
      ],
      "warnings": [
        "​Warnings ​ For external use only. Do not use near eyes inside nose, mouth or vagina on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas. Ask a doctor before us if you are allergic to ragweed, May cause breathing difficulty or an asthmatic attack. When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets in eyes, flush with water right away scalp itching or redness may occur. Stop use and ask doctor if breathing difficulty occurs eye irrirtation occurs skin or scalp irritation continues or infection occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "For external use only. Do not use near eyes inside nose, mouth or vagina on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas."
      ],
      "ask_doctor": [
        "Ask a doctor before us if you are allergic to ragweed, May cause breathing difficulty or an asthmatic attack."
      ],
      "when_using": [
        "When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets in eyes, flush with water right away scalp itching or redness may occur."
      ],
      "stop_use": [
        "Stop use and ask doctor if breathing difficulty occurs eye irrirtation occurs skin or scalp irritation continues or infection occurs"
      ],
      "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."
      ],
      "spl_unclassified_section": [
        "",
        "",
        "Consumer Information Kills Lice & Eliminates Nits in 3 simple steps ​ ​ ​STEP 1: APPLY • APLIQUE Apply shampoo ​on dry hair ​ ​ for 10 minutes. ​ STEP 2: REMOVE • RETIRE Remove lice and nits with comb provided. ​STEP 3: REPEAT • REPITA ​Repeat treatment 1 week later. ​Detailed Instructions Inside ​ ​BILINGUAL HOW-TO VIDEOS ​Visit HERKLINE USA on YouTube for step-by-step videos. Step 1 Step 2 Step 3 How to Video",
        "Distributed by MarcasUSA, Inc., El Segundo, CA 90245 • HerklineUSA.com Made in U.S.A 58-253-02v3.0"
      ],
      "dosage_and_administration": [
        "​ ​Directions ​Important: Read warnings before use. adults and children 2 years and over: Inspect check each household member with a magnifying glass in bright light for lice/nits (eggs) look for tiny nits near scalp, beginin at back of neck and behind ears examine small sections of hair at a time unlike dandruff which moves when touched, nits stick to the hair if either lice or nits are found, treat with this product ​Treat apply thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck. allow product to remain for 10 minutes, but no longer use warm water to form a lather, shampoo, then thoroughly rinse for head lice, towel dry hair and comb out tangles. ​Remove lice and their eggs (nits) use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove.) hair should remain slightly damp while removing nits if hair dries during combing dampen slightly with water for head lice, part hair into sections. Do one section at a time starting on top of head. Longer hair may take 1 to 2 hours. life a 1- to 2- inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp. Pin back each strand of hair after combing clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice froom coming back. after combing, thoroughly recheck for lice/nits. Repeat combing if necessary. a second treatment must be done in 7 to 10 days to kill any newly hatched lice If infestation continues, see a doctor for other treatments. ​children under 2 years: ​ aska doctor"
      ],
      "storage_and_handling": [
        "​Other Information do not freeze store at controlled room temperature, 20 °C to 25 ° C (68 ºF to 77 ºF) Questions or comments call (844) 437-5546 see package insert for additional information"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel - 236 mL Bottle Carton MAXIMUM STRENGTH • PROUDLY SERVING FAMILIES FOR • 38 YEARS HERKLIN® LICE TREATMENT Piperonyl butoxide 4% Pyrethrum extract (0.33% pyrethrins) Kills Lice & Eliminates Nits* Effective & safe for ages 2+ NEED HELP? • Toll Free (844) HERKLIN (437-5546) INCLUDES: Shampoo, Lice & Nit Comb LICE COMB INCLUDED 2 fl oz (59 mL) ​*Proper use of nit comb removes nits Carton"
      ],
      "set_id": "018e8b94-b52b-466c-8265-51fb68a67bcf",
      "id": "3fbdf14a-eb00-4fd1-b00e-01f8354f04cb",
      "effective_time": "20180716",
      "version": "1",
      "openfda": {
        "application_number": [
          "part358G"
        ],
        "brand_name": [
          "Herklin Lice Treatment"
        ],
        "generic_name": [
          "PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT"
        ],
        "manufacturer_name": [
          "MarcasUSA LLC"
        ],
        "product_ndc": [
          "75940-192"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PIPERONYL BUTOXIDE",
          "PYRETHRUM EXTRACT"
        ],
        "rxcui": [
          "283219",
          "1988409"
        ],
        "spl_id": [
          "3fbdf14a-eb00-4fd1-b00e-01f8354f04cb"
        ],
        "spl_set_id": [
          "018e8b94-b52b-466c-8265-51fb68a67bcf"
        ],
        "package_ndc": [
          "75940-192-09"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "LWK91TU9AH",
          "ZUM06L90GV"
        ]
      }
    }
  ]
}