FDA Label for Bella Flore

View Indications, Usage & Precautions

Bella Flore Product Label

The following document was submitted to the FDA by the labeler of this product Natureplex Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


* Please review the disclaimer below.