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Bella Flore

Medically reviewed on Aug 15, 2018

Dosage form: kit
Ingredients: POVIDONE-IODINE 0.3g in 100mL;
Labeler: Natureplex LLC
NDC Code: 67234-022

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Bella Flore
Medicated Douche

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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)

Established Pharmacological Class
SubstancePharmacological Class
Bella FloreDOUCHES
BELLA FLORE 
povidone-iodine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-022
Packaging
#Item CodePackage Description
1NDC:67234-022-011 KIT in 1 CARTON
2NDC:67234-022-021 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 8 mL
Part 22 BOTTLE, WITH APPLICATOR 266 mL
Part 1 of 2
POVIDONE-IODINE 
povidone-iodine douche
Product Information
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE0.3 g  in 100 mL
Packaging
#Item CodePackage Description
18 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/02/2012
Part 2 of 2
BELLA FLORE 
solution
Product Information
Route of AdministrationVAGINALDEA Schedule    
Ingredients
Ingredient NameQuantity
EDETATE DISODIUM 
COCO DIETHANOLAMIDE 
SODIUM BENZOATE 
SODIUM LAURETH-3 SULFATE 
SODIUM PHOSPHATE, TRIBASIC 
CITRIC ACID MONOHYDRATE 
WATER 
COCAMIDOPROPYL BETAINE 
Packaging
#Item CodePackage Description
1133 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/02/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/02/2012
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIOperations
Natureplex LLC062808196MANUFACTURE(67234-022)

 
Natureplex LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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