GYNO-BETADINE- povidone iodine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

Available from:

OASIS TRADING

Administration route:

VAGINAL

Prescription type:

OTC DRUG

Therapeutic indications:

Local treatment in the following cases: Candidate vaginitis, trichomonas vaginitis, non-specific and mixed infection, preoperative pre-operative treatment of obstetrics and gynecology, local cleaning and release Dilute 30 ml of water in about 1 liter of hot water and wash the inside and outside of vagina once or twice a day.Clean sterilizable vaginal cleaning, local cleaning, and deodorization once or twice a week.

Authorization status:

unapproved drug other

Summary of Product characteristics

GYNO-BETADINE- POVIDONE IODINE SOLUTION
OASIS TRADING
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
POVIDONE-IODINE
Local treatment in the following cases: Candidate vaginitis,
trichomonas vaginitis, non-specific and
mixed infection, preoperative pre-operative treatment of obstetrics
and gynecology, local cleaning and
release
Keep out of reach of children
Dilute 30 ml of water in about 1 liter of hot water and wash the
inside and outside of vagina once or
twice a day.Clean sterilizable vaginal cleaning, local cleaning, and
deodorization once or twice a week.
DO NOT USE
in the eyes
as a first aid antiseptic longer than one week
on individuals who are allergic or sensitive to iodine
over large areas of the body
KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, get medical help or contact a Poison Control Center
right away.
Water, etc.
For vaginal use only
GYNO-BETADINE
povidone iodine solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:726 8 9 -0 0 41
ROUTE OF ADMINISTRATION
VAGINAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0
7X4)
IODINE
10 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
OASIS TRADING
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:726 8 9 -0 0 41-1 18 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio
n Pro duct
11/21/20 18
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
11/21/20 18
LABELER -
OASIS T RADING (689991468)
REGISTRANT -
OASIS T RADING (689991468)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
OASIS TRADING
6 8 9 9 9 146 8
manufacture(726 8 9 -0 0 41) , relabel(726 8 9 -0 0 41)
Revised: 3/2019