Bella Flore
FDA Label NDC 67234-022

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureplex Llc for the product Bella Flore (NDC 67234-022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each bottle when mixed with packet), purpose, use, warnings, do not use, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Bottle When Mixed With Packet)

Povidone-iodine 0.3%

Purpose

Antimicrobial

Use

for temporary relief of minor vaginal irritation or itching

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

Otc - 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.

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

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 Ingredients

citric acid, edetate disodium, purified water, sodium benzoate, sodium lauryl sulfate, trisodium phosphate

Questions?

1-866-323-0107

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)

Principal Display Panel (133 mL Kit Carton)

* Please review the disclaimer below.