Povidone - Iodine 10%

SPL v3

SPL

SPL Set ID cc8d7fee-dcfe-4d36-844a-402f08375563

Route

TOPICAL

Published

Effective Date 2022-07-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Sodium Phosphate Dibasic Dihydrate Glycerin Polysorbate 80 Water Sodium Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-10-10

Description

POVIDONE IODINE 10%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Dosage and Administration

Clean the area. Apply product to the operative site prior to surgery.

Description

POVIDONE IODINE 10%

Section 42229-5

1-470-737-9424

Section 44425-7

Store at controlled room temperature 15º-30ºC (59º-86ºF).

Section 50565-1

Keep out of reach of children. If swallowed, get medical help, or contact a Posion Control Center (1-800-222-1222) right away.

Section 50566-9

irritation and redness develop
condition persists for more than 72 hours

Section 50567-7

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.

Section 50570-1

if allergic to iodine
in the eyes

Section 51727-6

Povidone-iodine 10%

Section 51945-4

NDC 82429-202-16

Gabar Health Sciences

Povidone-Iodine

10% Solution

Topical Antiseptic

1 Gallon (3.78 L)

Section 55105-1

Healthcare Antiseptic

Section 55106-9

POVIDONE IODINE 10%

Structured Label Content

Indications and Usage (34067-9)

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Dosage and Administration (34068-7)

Clean the area. Apply product to the operative site prior to surgery.

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

1-470-737-9424

Section 44425-7 (44425-7)

Store at controlled room temperature 15º-30ºC (59º-86ºF).

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help, or contact a Posion Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

irritation and redness develop
condition persists for more than 72 hours

Section 50567-7 (50567-7)

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.

Section 50570-1 (50570-1)

if allergic to iodine
in the eyes

Section 51727-6 (51727-6)

Povidone-iodine 10%

Section 51945-4 (51945-4)

NDC 82429-202-16

Gabar Health Sciences

Povidone-Iodine

10% Solution

Topical Antiseptic

1 Gallon (3.78 L)

Section 55105-1 (55105-1)

Healthcare Antiseptic

Section 55106-9 (55106-9)

POVIDONE IODINE 10%

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE DIBASIC DIHYDRATE", "unii": "94255I6E2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection", "34068-7": "Clean the area. Apply product to the operative site prior to surgery.", "34071-1": "For external use only", "42229-5": "1-470-737-9424", "44425-7": "Store at controlled room temperature 15º-30ºC (59º-86ºF).", "50565-1": "Keep out of reach of children. If swallowed, get medical help, or contact a Posion Control Center (1-800-222-1222) right away.", "50566-9": "irritation and redness develop condition persists for more than 72 hours", "50567-7": "For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.", "50570-1": "if allergic to iodine in the eyes", "51727-6": "Povidone-iodine 10%", "51945-4": "NDC 82429-202-16 Gabar Health Sciences Povidone-Iodine 10% Solution Topical Antiseptic 1 Gallon (3.78 L)", "55105-1": "Healthcare Antiseptic", "55106-9": "POVIDONE IODINE 10%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:34.400207 · Updated: 2026-03-06T01:18:05.484129