GYNO-BETADINE- povidone iodine suppository

United States - English - NLM (National Library of Medicine)

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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 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.
Authorization status:
unapproved drug other
Authorization number:
72689-0042-1

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.

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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

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

GYNO-BETADINE

povidone iodine suppository

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:726 8 9 -0 0 42

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

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYETHYLENE GLYCO L 150 0 (UNII: 1212Z7S33A)

OASIS TRADING

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:726 8 9 -0 0 42-1 10 in 1 BLISTER PACK; 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 42) , relabel(726 8 9 -0 0 42)

Revised: 3/2019

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