SPL v1
SPL
SPL Set ID 84a633dc-bd52-0571-e053-2a91aa0a6df8
Route
VAGINAL
Published
Effective Date 2018-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (200 mg)
Inactive Ingredients
Polyethylene Glycol 1500

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-11-21

Description

POVIDONE-IODINE


Medication Information

Warnings and Precautions

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.

Indications and Usage

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.

Dosage and Administration

For vaginal use only

Description

POVIDONE-IODINE

Section 50565-1

Keep out of reach of children

Section 51727-6

POLYETHYLENE GLYCOL 1540

Section 51945-4

Section 55105-1

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

Section 55106-9

POVIDONE-IODINE


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

For vaginal use only

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

POLYETHYLENE GLYCOL 1540

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

POVIDONE-IODINE


Advanced Ingredient Data


Raw Label Data

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