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topcare feminine

Topco Associates LLC

Topco Associates LLC. Feminine Douche Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

topcare feminine 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?

1-888-423-0139

Package/Label Principal Display Panel

feminine douche

antimicrobial

povidone-iodine

for relief of minor vaginal irritation & itching

MEDICATED

COMPARE TO SUMMER'S EVE® ACTIVE INGREDIENT

topcare feminine
Feminine Douche Carton Image 1 Feminine Douche Carton Image 2

topcare feminine

povidone-iodine KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-110
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-110-36 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part333A 2010-01-14


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