FRESH AND PURE- povidone-iodine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)

Available from:

L Perrigo Company

INN (International Name):

POVIDONE-IODINE

Composition:

POVIDONE-IODINE .3 g in 100 mL

Prescription type:

OTC DRUG

Therapeutic indications:

Antimicrobial for temporary relief of minor vaginal irritation or itching

Authorization status:

OTC monograph not final

Summary of Product characteristics

FRESH AND PURE- POVIDONE-IODINE
L PERRIGO COMPANY
_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._
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PERRIGO FRESH AND PURE DOUCHE DRUG FACTS
ACTIVE INGREDIENT (IN EACH BOTTLE WHEN MIXED WITH PACKET)
Povidone-iodine 0.3%
PURPOS E
Antimicrobial
US E
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