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.

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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

1

GYNO-BETADINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0041
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0041-1180 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/21/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0041) , relabel(72689-0041)

Revised: 3/2019
Document Id: 847e647b-a41e-758e-e053-2991aa0a67a4
Set id: 847fc6ba-a5c8-e840-e053-2991aa0ae007
Version: 1
Effective Time: 20190320
 
OASIS TRADING