{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sulfo lo Sulfur 3% Soap Bar .ALPHA.-TOCOPHEROL ACETATE, D- SULFUR SULFUR SODIUM TALLOWATE, BEEF SODIUM COCOATE SODIUM PALM KERNELATE WATER GLYCERIN SODIUM CHLORIDE PENTASODIUM PENTETATE ETIDRONATE TETRASODIUM BROWN IRON OXIDE TITANIUM DIOXIDE SHEA BUTTER BASIC YELLOW 5"
      ],
      "active_ingredient": [
        "Active ingredients Sulfur 3%"
      ],
      "purpose": [
        "Purpose Acne Treatment"
      ],
      "indications_and_usage": [
        "Uses Deep cleansing antibacterial soap for management of acne, blackheads and comedones."
      ],
      "warnings": [
        "Warnings • For external use only • Avoid contact with eyes, wash with water if exposed •Do no use on • broken skin • large areas of skin • When using this product • apply only to areas with acne • 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 • If undue irritation persists consult a physician • Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center."
      ],
      "do_not_use": [
        "•Do no use on • broken skin • large areas of skin"
      ],
      "when_using": [
        "• When using this product • apply only to areas with acne • 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 • If undue irritation persists consult a physician"
      ],
      "keep_out_of_reach_of_children": [
        "• Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center."
      ],
      "dosage_and_administration": [
        "Directions • Work into a lather and rinse with warm water • Use daily as skin cleanser or as directed by a physician."
      ],
      "storage_and_handling": [
        "Other information Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature]."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Sodium Tallowate, Sodium Cocoate/Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Sodium Chloride, Butyrospermum parkii (Shea) Butter, Yellow 5 (CI19140), Titanium Dioxide (CI77891), Pentasodium Pentetate, Tetrasodium Etidronate, Iron Oxides (CI77492), Tocopheryl Acetate"
      ],
      "package_label_principal_display_panel": [
        "NDC 0316-0118-35 sulfo lo® Cleansing Bar Soap Helps Treat and Manage Acne, Blackheads and Comedones DERMATOLOGIST RECOMMENDED Net wt. 3.5oz (99 grams) Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 www.crownlaboratories.com | 800.334.4286 | Made in the USA P9100.06 P910006"
      ],
      "set_id": "89577417-76a0-cb04-e053-2995a90a5733",
      "id": "4833e6b4-3673-08d5-e063-6394a90aa791",
      "effective_time": "20260112",
      "version": "6",
      "openfda": {
        "application_number": [
          "M006"
        ],
        "brand_name": [
          "Sulfo lo"
        ],
        "generic_name": [
          "SULFUR 3% SOAP BAR"
        ],
        "manufacturer_name": [
          "Crown Laboratories"
        ],
        "product_ndc": [
          "0316-0118"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SULFUR"
        ],
        "rxcui": [
          "212397",
          "248410"
        ],
        "spl_id": [
          "4833e6b4-3673-08d5-e063-6394a90aa791"
        ],
        "spl_set_id": [
          "89577417-76a0-cb04-e053-2995a90a5733"
        ],
        "package_ndc": [
          "0316-0118-35"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303160118357"
        ],
        "unii": [
          "70FD1KFU70"
        ]
      }
    }
  ]
}