Label: FRESH AND PURE- povidone-iodine
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- NDC Code(s): 0113-0110-36
- Packager: L Perrigo Company
- 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 January 26, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each bottle when mixed with packet)
- Purpose
- Use
- 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
CloseKeep 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
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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
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Fresh & Pure Douche Carton Image 2
- INGREDIENTS AND APPEARANCE
FRESH AND PURE
povidone-iodine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0110 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0110-36 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 PACKET 8 mL Part 2 2 BOTTLE 266 mL Part 1 of 2 MEDICATED POVIDONE-IODINE
povidone-iodine solution, concentrateProduct Information Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE .3 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/09/2009 Part 2 of 2 QUALITY DISPOSABLE DOUCHE
inactive doucheProduct Information Route of Administration VAGINAL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) NONOXYNOL-10 (UNII: K7O76887AP) PHOSPHORIC ACID (UNII: E4GA8884NN) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 133 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/09/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/09/2009 CloseLabeler - L Perrigo Company (006013346)