GYNO-BETADINE: Package Insert and Label Information

GYNO-BETADINE- povidone-iodine suppository
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

Put 200 mg deep into the vagina once a day. It is advisable to insert it in the evening before bedtime. To increase or decrease appropriately according to age and symptoms.

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.

POLYETHYLENE GLYCOL 1540

For vaginal use only

1
(click image for full-size original)

GYNO-BETADINE
povidone iodine suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72689-0042
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 200 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 1500
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72689-0042-1 10 SUPPOSITORY in 1 BLISTER PACK None
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 Operations
OASIS TRADING 689991468 manufacture (72689-0042), relabel (72689-0042)

Revised: 03/2019 OASIS TRADING

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