0138 Aplicare Pvp-i Gel Swabstick

SPL v3

SPL

SPL Set ID 0a48b8ef-f2d6-ed50-e063-6394a90a8ebe

Route

TOPICAL

Published

Effective Date 2024-09-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (10 mg)

Inactive Ingredients

Dodecamethylpentasiloxane Sodium Phosphate, Dibasic, Anhydrous Hydroxyethyl Cellulose, Unspecified Water Nonoxynol-2 Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

Povidone-iodine USP 10%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine USP 10%

Use

helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only

Directions

apply locally as needed

Do Not Use

if allergic to iodine
in the eyes

Package Label

Active Ingredient

Povidone-iodine USP 10%

Other Information

1% w/w titratable iodine
not made with natural rubber latex
for hospital or professional use only
protect from freezing, avoid excessive heat
store at room temperature

Inactive Ingredients

disodium phosphate, dodecamethylpentasiloxane, glycerol, hydroxyethylcellulose, nonylphenoxypoly (ethyleneoxy) ethanol-10, water

Manufacturing Information

www.medline.com

Aplicare is a registered trademark of Medline Industries, LP.

Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE.

Made in China.

Stop Use and Ask A Doctor If

redness, irritation, swelling or pain develops or persists for more than 72 hours
infection occurs

Keep Out of Reach of Children.

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

Structured Label Content

Use

helps reduce bacteria that potentially can cause skin infection

Purpose

Antiseptic

Warnings

For external use only

Directions

apply locally as needed

Do Not Use (Do not use)

if allergic to iodine
in the eyes

Package Label (Package label)

Active Ingredient (Active ingredient)

Povidone-iodine USP 10%

Other Information (Other information)

1% w/w titratable iodine
not made with natural rubber latex
for hospital or professional use only
protect from freezing, avoid excessive heat
store at room temperature

Inactive Ingredients (Inactive ingredients)

disodium phosphate, dodecamethylpentasiloxane, glycerol, hydroxyethylcellulose, nonylphenoxypoly (ethyleneoxy) ethanol-10, water

Manufacturing Information (Manufacturing information)

www.medline.com

Aplicare is a registered trademark of Medline Industries, LP.

Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE.

Made in China.

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

redness, irritation, swelling or pain develops or persists for more than 72 hours
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.

Advanced Ingredient Data

[{"name": "DODECAMETHYLPENTASILOXANE", "unii": "0QDQ2VQ5YJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "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"}, {"name": "NONOXYNOL-2", "unii": "U4A966MO25", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps reduce bacteria that potentially can cause skin infection", "Purpose": "Antiseptic", "Warnings": "For external use only", "Directions": "apply locally as needed", "Do not use": "if allergic to iodine in the eyes", "Active ingredient": "Povidone-iodine USP 10%", "Other information": "1% w/w titratable iodine not made with natural rubber latex for hospital or professional use only protect from freezing, avoid excessive heat store at room temperature", "Inactive ingredients": "disodium phosphate, dodecamethylpentasiloxane, glycerol, hydroxyethylcellulose, nonylphenoxypoly (ethyleneoxy) ethanol-10, water", "Manufacturing information": "www.medline.com ©2024 Medline Industries, LP Aplicare is a registered trademark of Medline Industries, LP. Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA 1-800-MEDLINE. Made in China.", "Stop use and ask a doctor if": "redness, irritation, swelling or pain develops or persists for more than 72 hours infection occurs", "Keep out of reach of children.": "In case of accidental ingestion, seek professional assistance or consult a poison control center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:47.626722 · Updated: 2026-03-14T23:11:35.907821