drug facts

drug facts

SPL v3

SPL

SPL Set ID 766ad4df-2100-4f26-bd8b-5c5a0918698e

Route

topical

Published

Effective Date 2021-03-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

iodine (1 g)

Inactive Ingredients

glycerin hydroxyethyl cellulose (2000 mpa.s at 1%) nonoxynol-10 anhydrous citric acid sodium hydroxide water potassium iodide

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2019-10-22

Purpose

Antiseptic

Description

Povidone Iodine USP 10%

Medication Information

Warnings

For external use only.

Purpose

Antiseptic

Directions

Apply product to skin as needed

Other Information

1 % titratable iodine
Avoid excessive heat
Store at room temperature
For hospital or professional use only
Not made with natural rubber latex

Inactive Ingredients

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

Description

Povidone Iodine USP 10%

Questions?

1-800-472-4346

Use

Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.

Section 50569-3

Ask a doctor before use if injuries are

deep or puncture wounds
serious burn

Do Not Use

if allergic to iodine
in the eyes

Active Ingredient

Povidone Iodine USP 10%

Stop Use and Ask A Doctor If

infection occurs
redness, irritation or swelling develops

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away

Principal Display Panel 2.3 Ml Item Label

NDC 0404-0119-01

HENRY SCHEIN ^®

REF 570-1549

POVIDONE-IODINE

SWABSTICKS

10% Povidone-Iodine

Single Packs

1 Swabstick/Pack

Do not re-use

Structured Label Content

Warnings

For external use only.

Purpose

Antiseptic

Directions

Apply product to skin as needed

Other Information (Other information)

1 % titratable iodine
Avoid excessive heat
Store at room temperature
For hospital or professional use only
Not made with natural rubber latex

Inactive Ingredients (Inactive ingredients)

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

Questions?

1-800-472-4346

Use

Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.

Section 50569-3 (50569-3)

Ask a doctor before use if injuries are

deep or puncture wounds
serious burn

Do Not Use (Do not use)

if allergic to iodine
in the eyes

Active Ingredient (Active ingredient)

Povidone Iodine USP 10%

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

infection occurs
redness, irritation or swelling develops

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

If swallowed, get medical help or contact a Poison Control Center right away

Principal Display Panel 2.3 Ml Item Label (Principal Display Panel - 2.3 mL Item Label)

NDC 0404-0119-01

HENRY SCHEIN ^®

REF 570-1549

POVIDONE-IODINE

SWABSTICKS

10% Povidone-Iodine

Single Packs

1 Swabstick/Pack

Do not re-use

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)", "unii": "S38J6RZN16", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-10", "unii": "K7O76887AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM IODIDE", "unii": "1C4QK22F9J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.", "50569-3": "Ask a doctor before use if injuries are deep or puncture wounds serious burn", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Apply product to skin as needed", "Do not use": "if allergic to iodine in the eyes", "Questions?": "1-800-472-4346", "Active ingredient": "Povidone Iodine USP 10%", "Other information": "1 % titratable iodine Avoid excessive heat Store at room temperature For hospital or professional use only Not made with natural rubber latex", "Inactive ingredients": "alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide", "Stop use and ask a doctor if": "infection occurs redness, irritation or swelling develops", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away", "Principal Display Panel - 2.3 mL Item Label": "NDC 0404-0119-01 HENRY SCHEIN ® REF 570-1549 POVIDONE-IODINE SWABSTICKS 10% Povidone-Iodine Single Packs 1 Swabstick/Pack Do not re-use"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:23.696903 · Updated: 2026-03-14T23:01:24.251815