Povidone Iodine Topical Solution Usp

SPL v1

SPL

SPL Set ID 92b6a38e-c7bb-45e2-9c2a-7993ed1bac36

Route

TOPICAL

Published

Effective Date 2024-02-15

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, Anhydrous Nonoxynol-9 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 1980-01-01

Description

Povidone Iodine 10% (available iodine 1%)

Purpose

Topical antiseptic

Medication Information

Purpose

Topical antiseptic

Description

Povidone Iodine 10% (available iodine 1%)

Uses

First aid topical antiseptic to help prevent infection in

minor cuts
scrapes
abrasions

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help immediately or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if

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

Section 50569-3

Ask a dcotor before use if you have

deep or puncture wounds
serious burns

Section 50570-1

Do not use

on animal bits
in or near the eyes or over large portions of the body

Warnings

For external use only.

do not get in eyes

Packaging

Directions

Adults and children 12 years of age and older:

reverse cardboard sleeve
crush at dot between thumb and forefinger to release fluid
gently wipes injured area to clean and disinfect
dispose of swab peoperly
do not reuse swab

Children under 12 years of age: ask a doctor

Active Ingredient

Povidone Iodine 10% (available iodine 1%)

Other Information

Store at room temperaturem 59° - 86°F (15° - 30°C) away from light. Keep from freezing or excessive heat.

Inactive Ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Structured Label Content

Uses

First aid topical antiseptic to help prevent infection in

minor cuts
scrapes
abrasions

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help immediately or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

Section 50569-3 (50569-3)

Ask a dcotor before use if you have

deep or puncture wounds
serious burns

Section 50570-1 (50570-1)

Do not use

on animal bits
in or near the eyes or over large portions of the body

Purpose

Topical antiseptic

Warnings

For external use only.

do not get in eyes

Packaging

Directions

Adults and children 12 years of age and older:

reverse cardboard sleeve
crush at dot between thumb and forefinger to release fluid
gently wipes injured area to clean and disinfect
dispose of swab peoperly
do not reuse swab

Children under 12 years of age: ask a doctor

Active Ingredient

Povidone Iodine 10% (available iodine 1%)

Other Information (Other information)

Store at room temperaturem 59° - 86°F (15° - 30°C) away from light. Keep from freezing or excessive heat.

Inactive Ingredients (Inactive ingredients)

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Advanced Ingredient Data

[{"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First aid topical antiseptic to help prevent infection in minor cuts scrapes abrasions", "50565-1": "Keep out of reach of children . If swallowed, get medical help immediately or contact a Poison Control Center right away. 1-800-222-1222", "50566-9": "Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases infection occurs", "50569-3": "Ask a dcotor before use if you have deep or puncture wounds serious burns", "50570-1": "Do not use on animal bits in or near the eyes or over large portions of the body", "Purpose": "Topical antiseptic", "Warnings": "For external use only. do not get in eyes", "Directions": "Adults and children 12 years of age and older: r everse cardboard sleeve crush at dot between thumb and forefinger to release fluid gently wipes injured area to clean and disinfect dispose of swab peoperly do not reuse swab Children under 12 years of age: ask a doctor", "Active Ingredient": "Povidone Iodine 10% (available iodine 1%)", "Other information": " Store at room temperaturem 59° - 86°F (15° - 30°C) away from light. Keep from freezing or excessive heat.", "Inactive ingredients": "citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:47.686537 · Updated: 2026-03-14T23:02:32.213463