GYNO-BETADINE- povidone iodine solution

GYNO-BETADINE by

Drug Labeling and Warnings

GYNO-BETADINE by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

POVIDONE-IODINE

PURPOSE

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

Keep out of reach of children

INDICATIONS & USAGE

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.

WARNINGS

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.

INACTIVE INGREDIENT

Water, etc.

DOSAGE & ADMINISTRATION

For vaginal use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GYNO-BETADINE 
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0041
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0041-1	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/21/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS TRADING		689991468	manufacture(72689-0041) , relabel(72689-0041)