{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "DRMITSUI SILICONE SCAR REMOVER Silicone CARBOMER WATER PROPYLENE GLYCOL SODIUM BENZOATE METHYLPARABEN DIMETHICONE DIMETHICONE POLYSORBATE 80 TRIETHANOLAMINE EDETATE DISODIUM"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS Silicone 5%"
      ],
      "purpose": [
        "PURPOSE Skin Protectant FAST RELIEF KELOLD ACNE PIT STRECH MARKS SURGICAL SCARS HYPERTROPHIC SCARS"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Water, Propylene Glycol, Polysorbate-80, Carbomer, Triethanolamine, Sodium Benzoate,Methylparaben, Disodium Edetate."
      ],
      "indications_and_usage": [
        "USES ●Clean the scarred area with water,pat dry. ●Apply an appropriate amount of this product to the scarred area and spread evenly. ●Gently massage the scarred area for 5 to 10 minutes. Use 2 to 3 times daily or as directed by your healthcare provide"
      ],
      "dosage_and_administration": [
        "●Clean the scarred area with water,pat dry. ●Apply an appropriate amount of this product to the scarred area and spread evenly. ●Gently massage the scarred area for 5 to 10 minutes. Use 2 to 3 times daily or as directed by your healthcare provide"
      ],
      "general_precautions": [
        "DIRECTIONS For use in assisting the improvement of pathological skin scars and preventing the formation of pathological skin scars. Not for use on wounds that have not fully healed."
      ],
      "warnings": [
        "WARNINGS ●This product is intended for patients with hypertrophic scars who meet the indications outlined in this manual. ●Consumers may use this product as directed in this manual or as prescribed by a physician.For external use only. ●Discontinue use immediately if allergic reactions occur. ●Use within one year after opening (store in a cool,dry place). ●Consult a healthcare professional before using this product concurrently with other treatments or medications. Dispose of used product as regular household waste. ●Keep out of reach of children."
      ],
      "stop_use": [
        ""
      ],
      "keep_out_of_reach_of_children": [
        "●Keep out of reach of children."
      ],
      "precautions": [
        "OTHER INFORMATION Seal tightly and store in a ventilated,dry,cool,and clean place."
      ],
      "questions": [
        "QUESTIONS TELEPHONE NUMBER:1076-482-3458 TIME:09:00-18:00"
      ],
      "spl_unclassified_section": [
        "DISTRIBUTOR Mitsui Pharmaceutical Co., Ltd. ADDRESS 10-24 Mega Awaza Building,3-Chome, Tensilihonmachi,Nishi-Ku, Oban City, Osaka Prefecture. MANUFACTURED BY Zhenping Renren Industry Co.,Ltd. ADDRESS No.10, Xinxing Road, Chanye Jiju District, Zhenping County,Nanyang, Henan, China"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL"
      ],
      "set_id": "4c2e9bd9-062d-670d-e063-6294a90ae1f4",
      "id": "4c2e9bd9-062e-670d-e063-6294a90ae1f4",
      "effective_time": "20260304",
      "version": "1",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "DRMITSUI SILICONE SCAR REMOVER"
        ],
        "generic_name": [
          "SILICONE"
        ],
        "manufacturer_name": [
          "Zhenping Renren Industry Co., Ltd."
        ],
        "product_ndc": [
          "87096-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "CUTANEOUS",
          "TRANSDERMAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "spl_id": [
          "4c2e9bd9-062e-670d-e063-6294a90ae1f4"
        ],
        "spl_set_id": [
          "4c2e9bd9-062d-670d-e063-6294a90ae1f4"
        ],
        "package_ndc": [
          "87096-003-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "4573638420343"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}