1905 10% pvp-i scrub, non-sterile

SPL v18

SPL

SPL Set ID 7302a2f8-a600-4200-bc4e-309e4c190fe5

Route

topical

Published

Effective Date 2017-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

iodine (10 mg)

Inactive Ingredients

citric acid monohydrate sodium phosphate, dibasic sodium hydroxide nonoxynol-9 water

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 1998-09-01 Until 2022-06-01

Purpose

Antiseptic

Description

Povidone-iodine USP 10%

Medication Information

Warnings

For external use only

Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Uses

antiseptic skin preparation
single use when used for patient preoperative skin preparation and/or preinjection indications.

Purpose

Antiseptic

Directions

apply locally as needed

Other Information

1% titratable iodine
not made with Natural Rubber Latex
for hospital or professional use only

Inactive Ingredients

• citric acid

• disodium phosphate

• nonoxynol-9

• sodium hydroxide

• water

Description

Povidone-iodine USP 10%

Do Not Use

in the eyes
on individuals allergic or sensitive to iodine

Package Label

Active Ingredient

Povidone-iodine USP 10%

Questions Or Comments?

1 800-633-5463

Monday - Friday

8:30 AM -5:00 PM EST

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Made in USA with domestic and foreign materials

1-800-633-5463

REF: APL82332

RL17HND

Stop Use and Ask A Doctor If

infection occurs
redness, irritation, swelling or pain persists or increases

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Ask A Doctor Before Use If Injuries Are

deep or puncture wounds
serious burns

Structured Label Content

Warnings

For external use only

Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Uses

antiseptic skin preparation
single use when used for patient preoperative skin preparation and/or preinjection indications.

Purpose

Antiseptic

Directions

apply locally as needed

Other Information (Other information)

1% titratable iodine
not made with Natural Rubber Latex
for hospital or professional use only

Inactive Ingredients (Inactive ingredients)

• citric acid

• disodium phosphate

• nonoxynol-9

• sodium hydroxide

• water

Do Not Use (Do not use)

in the eyes
on individuals allergic or sensitive to iodine

Package Label

Active Ingredient (Active ingredient)

Povidone-iodine USP 10%

Questions Or Comments? (Questions or comments?)

1 800-633-5463

Monday - Friday

8:30 AM -5:00 PM EST

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Made in USA with domestic and foreign materials

1-800-633-5463

REF: APL82332

RL17HND

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

infection occurs
redness, irritation, swelling or pain persists or increases

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Ask A Doctor Before Use If Injuries Are (Ask a doctor before use if injuries are)

deep or puncture wounds
serious burns

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "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)

{"Uses": "antiseptic skin preparation single use when used for patient preoperative skin preparation and/or preinjection indications.", "Purpose": "Antiseptic", "Warnings": "For external use only Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.", "Directions": "apply locally as needed", "Do not use": "in the eyes on individuals allergic or sensitive to iodine", "Active ingredient": "Povidone-iodine USP 10%", "Other information": "1% titratable iodine not made with Natural Rubber Latex for hospital or professional use only", "Inactive ingredients": "• citric acid • disodium phosphate • nonoxynol-9 • sodium hydroxide • water", "Questions or comments?": "1 800-633-5463 Monday - Friday 8:30 AM -5:00 PM EST", "Manufacturing Information": "Manufactured by: Aplicare Products, LLC 550 Research Parkway, Meriden, CT 06450 USA Made in USA with domestic and foreign materials 1-800-633-5463 REF: APL82332 RL17HND", "Stop use and ask a doctor if": "infection occurs redness, irritation, swelling or pain persists or increases", "Keep out of reach of children.": "In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.", "Ask a doctor before use if injuries are": "deep or puncture wounds serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:48.344167 · Updated: 2026-03-14T23:11:37.729091