Fresh and pure kit

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

  1. if you have an iodine sensitivity
  2. to prevent pregnancy
  3. during pregnancy
  4. 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
  5. 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
  6. to self-treat or prevent an STD or PID
  7. after exposure to an STD

Stop use and ask a doctor if

  1. douching results in pain, soreness, swelling, redness, itching, excessive dryness, or irritation
  2. 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:

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

When and how to douche:

  1. use once daily for seven days, even if symptoms disappear sooner
  2. gently insert nozzle into your vagina, no more than 3 inches, and slowly squeeze bottle
  3. do not close the vaginal opening; douching solution should flow freely out of vagina
  4. use while sitting on the toilet, in the tub, or while standing in the shower

Other information

  1. store at 20-25C (68-77F)
  2. 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.
  3. see a doctor right away if you have symptoms of PID or STD
  4. 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

Ingredients and appearance - Product information

Fresh and pure kit- Povidone-iodine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0113-0110
Route of Administration Vaginal

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part333A USA

Labeler - L. Perrigo Company( 006013346)

Package/label principal display panel

Compare to Summers Eve® Douche Active Ingredient

fresh & pure

douche

MEDICATED

Antimicrobial

Povidone-Iodine

For Relief of Minor Vaginal Irritation & Itching

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Fresh & Pure Douche Carton Image 1 Fresh & Pure Douche Carton Image 1

Fresh & Pure Douche Carton Image 2