{
  "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": "2026-10-27",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Oxy 10 Vanishing benzoyl peroxide ANHYDROUS CITRIC ACID CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) DIAZOLIDINYL UREA DIMETHICONE DOCUSATE SODIUM EDETATE DISODIUM GLYCERIN LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER PROPYLENE GLYCOL WATER SILICON DIOXIDE SODIUM CITRATE SODIUM HYDROXIDE XANTHAN GUM BENZOYL PEROXIDE BENZOYL PEROXIDE"
      ],
      "active_ingredient": [
        "Active ingredient Benzoyl peroxide 10%"
      ],
      "purpose": [
        "Purpose Acne treatment"
      ],
      "indications_and_usage": [
        "Uses treats and helps prevent acne"
      ],
      "warnings": [
        "Warnings For external use only Do Not Use if you have very sensitive skin are sensitive to benzoyl peroxide 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. avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration. Stop use and ask a doctor if irritation becomes severe If pregnant or breast-feeding Ask a health professional before use."
      ],
      "do_not_use": [
        "Do Not Use if you have very sensitive skin are sensitive to benzoyl peroxide"
      ],
      "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. avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration."
      ],
      "stop_use": [
        "Stop use and ask a doctor if irritation becomes severe"
      ],
      "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 clean skin thoroughly before applying this product cover entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients anhydrous citric acid, carbomer homopolymer, diazolidinyl urea, diethylhexyl sodium sulfosuccinate, dimethicone, edetate disodium, glycerin, lauryl methacrylate/glycol dimethacrylate crosspolymer, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, xanthan gum"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel Oxy 10 Vanishing"
      ],
      "set_id": "d499b69a-25aa-4e3d-a07e-a774bc0d65f1",
      "id": "297976fe-a0e0-7e3e-e063-6394a90a0bc2",
      "effective_time": "20241217",
      "version": "4",
      "openfda": {
        "application_number": [
          "M006"
        ],
        "brand_name": [
          "Oxy 10 Vanishing"
        ],
        "generic_name": [
          "BENZOYL PEROXIDE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8353"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZOYL PEROXIDE"
        ],
        "rxcui": [
          "106310"
        ],
        "spl_id": [
          "297976fe-a0e0-7e3e-e063-6394a90a0bc2"
        ],
        "spl_set_id": [
          "d499b69a-25aa-4e3d-a07e-a774bc0d65f1"
        ],
        "package_ndc": [
          "10742-8353-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "W9WZN9A0GM"
        ]
      }
    }
  ]
}