42339-003 antiseptic povidone-iodine prep pad 10% povidone-iodine, 1% available iodine. shandong haiyan medical manufacture co., ltd. www.…

42339-003 antiseptic povidone-iodine prep pad 10% povidone-iodine, 1% available iodine. shandong haiyan medical manufacture co., ltd. www. haiyan-medical.com

SPL v4

SPL

SPL Set ID c9187a07-92d5-15ac-e053-2995a90af4cb

Route

topical

Published

Effective Date 2012-03-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

iodine (9.43 g)

Inactive Ingredients

citric acid monohydrate sodium phosphate water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2012-02-18

Purpose

Antiseptic

Description

Povidone Iodine 10% w/w (equivalent to iodine 1%)

Medication Information

Warnings

For external use only.

Discontinue use if irritation and redness develop.

Purpose

Antiseptic

Directions

Apply locally as needed.

Other Information

Store at room temperature: 59°- 86°F(15 - 30℃)

Inactive Ingredients

Purified Water

Description

Povidone Iodine 10% w/w (equivalent to iodine 1%)

Use

Antiseptic for preparation of the skin.

Section 50565-1

Keep out of reach of Children.

Section 51945-4

Active Ingredient

Povidone Iodine 10% w/w (equivalent to iodine 1%)

Structured Label Content

Warnings

For external use only.

Discontinue use if irritation and redness develop.

Purpose

Antiseptic

Directions

Apply locally as needed.

Other Information

Store at room temperature: 59°- 86°F(15 - 30℃)

Inactive Ingredients (Inactive ingredients)

Purified Water

Use

Antiseptic for preparation of the skin.

Section 50565-1 (50565-1)

Keep out of reach of Children.

Section 51945-4 (51945-4)

Active Ingredient

Povidone Iodine 10% w/w (equivalent to iodine 1%)

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE", "unii": "SE337SVY37", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "9.43", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": "Antiseptic for preparation of the skin.", "50565-1": "Keep out of reach of Children.", "Purpose": "Antiseptic", "Warnings": "For external use only. Discontinue use if irritation and redness develop.", "Directions": "Apply locally as needed. Other Information Store at room temperature: 59°- 86°F(15 - 30℃)", "Active Ingredient": "Povidone Iodine 10% w/w (equivalent to iodine 1%)", "Inactive ingredients": "Purified Water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:17.636138 · Updated: 2026-03-14T23:04:54.043845