Bella Flore

Manufacturer
Natureplex LLC
Effective date
2021-02-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:37:39

Label at a glance#

ProductBella Flore
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

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 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 ...

Storage and handling

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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each bottle when mixed with packet)

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine 0.3%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

for temporary relief of minor vaginal irritation or itching

Warnings

WARNINGS SECTION

For vaginal use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

  • douching results in pain, soreness, swelling, redness, itching, excessive dryness, or irritation
  • symptoms continue after 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Preparing the douche

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-866-323-0107

PRINCIPAL DISPLAY PANEL - 133 mL Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312556povidone-iodine 0.3 % DouchePSN4
312556povidone-iodine 3 MG/ML DoucheSCD4
312556povidone-iodine 0.3 % DoucheSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-022-01Bella Flore1 in 1 CARTONKIT14
67234-022-02Bella Flore1 in 1 CARTONKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-022BELLA FLORE (POVIDONE-IODINE) KIT [NATUREPLEX LLC]4Legacy NDC, 2 package rows20210203_4669d7d2-4d4b-46d4-abca-088931cf6f04.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67234-02267234-022-01, 67234-022-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4e2414b0-e8f1-4a9e-98dd-cdb190918fab4669d7d2-4d4b-46d4-abca-088931cf6f042021-02-01WarningsExact identifier
spl id: 4e2414b0-e8f1-4a9e-98dd-cdb190918fab
spl set id: 4669d7d2-4d4b-46d4-abca-088931cf6f04

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.