fresh and pure

Dosage form: kit
Ingredients: POVIDONE-IODINE .3g in 100mL;
Labeler: L Perrigo Company
NDC Code: 0113-0110

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.

Perrigo Fresh and Pure 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
  • 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. (1-800-222-1222)

Directions

Preparing the douche:

  • remove cap, discard
  • carefully open the medicated packet and pour into the douche bottle. The contents can stain certain materials
  • screw nozzle onto the bottle
  • swirl bottle gently to mix

When and how to douche:

  • use once daily for seven days, even if symptoms disappear sooner
  • gently insert nozzle into your 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
  • store at 20-25°C (68-77°F)
  • 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
  • tamper evident: carton and douche concentrate packet sealed for safety. Do not use if printed seal on carton top or bottom flap is broken or missing, or packet is leaking.

Inactive ingredients

dibasic sodium phosphate, glycerin, hydrogen peroxide, nonoxynol-10, phosphoric acid, purified water 

Questions or comments?

1-800-367-4477

Package/Label Principal Display Panel

Compare to Summer’s Eve® Douche Active Ingredient

fresh & pure

douche

MEDICATED

Antimicrobial

Povidone-Iodine

For Relief of Minor Vaginal Irritation & Itching

# {“#” must represent number of bottles in carton}

Fresh & Pure Douche Carton Image 1

Fresh & Pure Douche Carton Image 2

FRESH AND PURE 
povidone-iodine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0110
Packaging
#Item CodePackage Description
1NDC:0113-0110-361 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 PACKET 8 mL
Part 22 BOTTLE 266 mL
Part 1 of 2
MEDICATED POVIDONE-IODINE 
povidone-iodine solution, concentrate
Product Information
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE.3 g  in 100 mL
Packaging
#Item CodePackage Description
14 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/09/2009
Part 2 of 2
QUALITY DISPOSABLE DOUCHE 
inactive douche
Product Information
Route of AdministrationVAGINALDEA Schedule    
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC 
GLYCERIN 
HYDROGEN PEROXIDE 
NONOXYNOL-10 
PHOSPHORIC ACID 
WATER 
Packaging
#Item CodePackage Description
1133 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/09/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/09/2009
Labeler - L Perrigo Company (006013346)

Revised: 01/2012
 
L Perrigo Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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