Label: BELLA FLORE- povidone-iodine kit
- NDC Code(s): 67234-022-01, 67234-022-02
- Packager: Natureplex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each bottle when mixed with packet)
- Purpose
- Use
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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
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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
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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
- Questions?
- PRINCIPAL DISPLAY PANEL - 133 mL Kit Carton
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INGREDIENTS AND APPEARANCE
BELLA FLORE
povidone-iodine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-022 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-022-01 1 in 1 CARTON 01/02/2012 2 NDC:67234-022-02 1 in 1 CARTON 01/02/2012 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 8 mL Part 2 2 BOTTLE, WITH APPLICATOR 266 mL Part 1 of 2 POVIDONE-IODINE
povidone-iodine doucheProduct Information Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/02/2012 Part 2 of 2 BELLA FLORE
douches solutionProduct Information Route of Administration VAGINAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/02/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/02/2012 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-022)
