BELLA FLORE- povidone-iodine kit

Bella Flore by

Drug Labeling and Warnings

Bella Flore by is a Otc medication manufactured, distributed, or labeled by Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

BELLA FLORE 
povidone-iodine kit

Product 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 douche

Product 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

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 solution

Product Information
Route of Administration	VAGINAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	COCO DIETHANOLAMIDE (UNII: 92005F972D)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

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)