120 Antiseptic Gel Swabs Povidone-iodine Usp 10%

SPL v2

SPL

SPL Set ID 11fd1661-1b8c-b65b-e063-6394a90af89b

Route

TOPICAL

Published

Effective Date 2024-07-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (10 mg)

Inactive Ingredients

Nonoxynol-10 Sodium Phosphate, Dibasic, Anhydrous Hydroxyethyl Cellulose, Unspecified Dimethicone, Unspecified Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Povidone-iodine USP 10%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine USP 10%

Uses

antiseptic skin preparation
help reduce bacteria that potentially can cause skin infections

Label

Warnings

For external use only.

Directions

Swab locally as needed.

Do Not Use

if allergic to iodine
in the eyes
on children less than 3 years old

Active Ingredient

Povidone-iodine USP 10%

Other Information

1% titratable iodine
not made with natural rubber latex
for hospital or professional use only
store product upright

Inactive Ingredients

disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water

Avoid Excessive Heat.

Protect from freezing, avoid excessive heat.

Temperature limits: 15˚C-30˚C.

Manufacturing Information

Made in USA by: Medline Industries, LP

Three Lakes Drive,

Northfield, IL 60093 USA.

REF: MDS1982

1-800-MEDLINE V2 RB24HND

www.medline.com

Stop Use and Ask A Doctor If

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

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

Uses

antiseptic skin preparation
help reduce bacteria that potentially can cause skin infections

Label

Purpose

Antiseptic

Warnings

For external use only.

Directions

Swab locally as needed.

Do Not Use (Do not use)

if allergic to iodine
in the eyes
on children less than 3 years old

Active Ingredient

Povidone-iodine USP 10%

Other Information (Other information)

1% titratable iodine
not made with natural rubber latex
for hospital or professional use only
store product upright

Inactive Ingredients (Inactive ingredients)

disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water

Avoid Excessive Heat. (Avoid excessive heat.)

Protect from freezing, avoid excessive heat.

Temperature limits: 15˚C-30˚C.

Manufacturing Information

Made in USA by: Medline Industries, LP

Three Lakes Drive,

Northfield, IL 60093 USA.

REF: MDS1982

1-800-MEDLINE V2 RB24HND

www.medline.com

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

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

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": "NONOXYNOL-10", "unii": "K7O76887AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE, UNSPECIFIED", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "antiseptic skin preparation help reduce bacteria that potentially can cause skin infections", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Swab locally as needed.", "Do not use": "if allergic to iodine in the eyes on children less than 3 years old", "Active Ingredient": "Povidone-iodine USP 10%", "Other information": "1% titratable iodine not made with natural rubber latex for hospital or professional use only store product upright", "Inactive ingredients": "disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water", "Avoid excessive heat.": "Protect from freezing, avoid excessive heat. Temperature limits: 15˚C-30˚C.", "Manufacturing Information": "Made in USA by: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA. REF: MDS1982 1-800-MEDLINE V2 RB24HND www.medline.com", "Stop use and ask a doctor if": "redness, irritation, swelling or pain persists or increases infection occurs", "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: 2026-02-15T12:03:19.715205 · Updated: 2026-03-14T23:03:21.577672