{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Bella Flore POVIDONE-IODINE POVIDONE-IODINE POVIDONE-IODINE POVIDONE-IODINE IODINE EDETATE DISODIUM COCO DIETHANOLAMIDE SODIUM BENZOATE SODIUM LAURETH-3 SULFATE SODIUM PHOSPHATE, TRIBASIC CITRIC ACID MONOHYDRATE WATER COCAMIDOPROPYL BETAINE Bella Flore"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each bottle when mixed with packet) Povidone-iodine 0.3%"
      ],
      "purpose": [
        "Purpose Antimicrobial"
      ],
      "indications_and_usage": [
        "Use for temporary relief of minor vaginal irritation or itching"
      ],
      "warnings": [
        "Warnings For vaginal use only Do not use if you have an iodine sensitivity to prevent pregnancy if you are trying to become pregnant or during pregnancy if you have symptoms of pelvic inflammatory disease (PID), such as lower abdominal pain, fever, chills, nausea, vomiting, and/or a pus-like yellow cervical discharge; see a doctor right away if you have symptoms of sexually transmitted diseases (STD), such as vaginal discharge of an unusual amount, color, or odor, painful and/or frequent urination, genital sores or ulcers; see a doctor right away to self-treat or prevent an STD or PID after exposure to an STD Stop use and ask a doctor if douching results in pain, soreness, swelling, redness, itching, excessive dryness, or irritation symptoms continue after 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use if you have an iodine sensitivity to prevent pregnancy if you are trying to become pregnant or during pregnancy if you have symptoms of pelvic inflammatory disease (PID), such as lower abdominal pain, fever, chills, nausea, vomiting, and/or a pus-like yellow cervical discharge; see a doctor right away if you have symptoms of sexually transmitted diseases (STD), such as vaginal discharge of an unusual amount, color, or odor, painful and/or frequent urination, genital sores or ulcers; see a doctor right away to self-treat or prevent an STD or PID after exposure to an STD"
      ],
      "stop_use": [
        "Stop use and ask a doctor if douching results in pain, soreness, swelling, redness, itching, excessive dryness, or irritation symptoms continue after 7 days"
      ],
      "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 Preparing the douche remove sanitary overwrap and unscrew nozzle cap carefully open the medicated packet and pour into the douche bottle. The contents can stain certain materials. screw the nozzle cap back onto the bottle swirl bottle gently to mix after mixing, use within one hour When and how to douche use once daily for seven days, even if symptoms disappear sooner gently insert nozzle into vagina, no more than 3 inches, and slowly squeeze bottle do not close the vaginal opening ; douching solution should flow freely out of vagina use while sitting on the toilet, in the tub, or while standing in the shower"
      ],
      "storage_and_handling": [
        "Other information an association has been reported between douching and pelvic inflammatory disease (PID), ectopic pregnancy, and infertility. It is not currently known whether douching is causally related to these conditions, but women should be aware of this association. see a doctor right away if you have symptoms of PID or STD bottle and douche concentrate packet sealed for your protection. Do not use if seal under cap is torn or missing, or packet is leaking."
      ],
      "inactive_ingredient": [
        "Inactive ingredients citric acid, edetate disodium, purified water, sodium benzoate, sodium lauryl sulfate, trisodium phosphate"
      ],
      "questions": [
        "Questions? 1-866-323-0107"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 133 mL Kit Carton bella flore douche medicated pH-Balanced Relieves Minor Vaginal Irritation & Itching *Compare To Summer's Eve® 2 Two Unit 4.5 fl. oz.(133mL) PRINCIPAL DISPLAY PANEL - 133 mL Kit Carton"
      ],
      "set_id": "4669d7d2-4d4b-46d4-abca-088931cf6f04",
      "id": "4e2414b0-e8f1-4a9e-98dd-cdb190918fab",
      "effective_time": "20210201",
      "version": "4",
      "openfda": {}
    }
  ]
}