{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "SEYTU Spot Salicylic Acid SALICYLIC ACID SALICYLIC ACID ALCOHOL ALLANTOIN AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) BUTYLENE GLYCOL ETHYLHEXYLGLYCERIN MADECASSOSIDE PHENOXYETHANOL PURSLANE PROPYLENE GLYCOL SODIUM HYDROXIDE EDETATE SODIUM WATER"
      ],
      "active_ingredient": [
        "Active Ingredient Salicylic Acid 2.0%"
      ],
      "purpose": [
        "Purpose Acne Treatment Gel"
      ],
      "indications_and_usage": [
        "Uses • For the treatment of acne • Reduce the severity of new acne pimples, blackheads, or whiteheads"
      ],
      "warnings": [
        "Warnings • For external use only • If experience skin irritation or prolonged stinging, stop using the product and consult your physician When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time • Follow the use instructions on the label • Do not exceed the recommended applications Keep out of reach of children. • If swallowed, get medical help or contact a poison control center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water."
      ],
      "when_using": [
        "When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time • Follow the use instructions on the label • Do not exceed the recommended applications"
      ],
      "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. Avoid contact with eyes. If contact occurs, flush thoroughly with water."
      ],
      "dosage_and_administration": [
        "Directions • Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • If bothersome dryness or peeling occurs, reduce application to once a day or every other day"
      ],
      "other_safety_information": [
        "Other Information Do not use if the security seal has been broken"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Alcohol Denat., Allantoin, Ammonium Polyacryloyldimethyl Taurate, Bacillus Ferment Filtrate Extract, Butylene Glycol, Ethylhexylglycerin, Madecassoside, Phenoxyethanol, Portulaca Oleracea Extract, Propylene Glycol, Sodium Hydroxide, Tetrasodium EDTA, Water (Aqua)."
      ],
      "questions": [
        "Questions? CUSTOMER SERVICE: U.S.A. 1 844 847 3988. seytu.omnilife.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel SEYTÚ ® SYSTEM SPOT-SPECIALIST Spot Gel Gel Localizado Acne Treatment Salicylic Acid 2% Ácido Salicílico 2% Postbiotics Postbióticos Madecassoside 0.5 fl Oz. (15 mL) MADE IN USA WITH GLOBALLY SOURCED INGREDIENTS PRODUCT NOT TESTED ON ANIMALS HYPOALLERGENIC PRODUCT IMPORTED AND / OR DISTRIBUTED BY: OMNILIFE USA, INC. 3900 SOUTH FREEWAY, FORT WORTH, TX 76110. Label image-01"
      ],
      "set_id": "68252aa0-36cd-4380-8898-16a5e4731866",
      "id": "68252aa0-36cd-4380-8898-16a5e4731866",
      "effective_time": "20240823",
      "version": "1",
      "openfda": {
        "application_number": [
          "M006"
        ],
        "brand_name": [
          "SEYTU Spot"
        ],
        "generic_name": [
          "SALICYLIC ACID"
        ],
        "manufacturer_name": [
          "Omnilife USA, Inc."
        ],
        "product_ndc": [
          "84271-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SALICYLIC ACID"
        ],
        "rxcui": [
          "346298"
        ],
        "spl_id": [
          "68252aa0-36cd-4380-8898-16a5e4731866"
        ],
        "spl_set_id": [
          "68252aa0-36cd-4380-8898-16a5e4731866"
        ],
        "package_ndc": [
          "84271-002-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "O414PZ4LPZ"
        ]
      }
    }
  ]
}