Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 5bdac950-11b8-483e-a40e-0f2bca294d02

Route

TOPICAL

Published

Effective Date 2010-04-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Povidone-iodine (.10 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2006-09-13

Description

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Medication Information

Warnings and Precautions

Purpose

Antiseptic

Description

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Use

First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Do Not

use in the eyes
use on individuals who are allergic or sensitive to iodine
apply over large areas of the body

Section 42229-5

Section 50567-7

Section 50568-5

Section 53413-1

Section 53414-9

Warnings

For external use only.

Directions

Clean the affected area
Apply a small amount of this product to the area 1-3 times daily
May be covered with a sterile bandage
If bandaged, let dry first

Active Ingredient

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Label Information

Compare to active ingredient of Betadine® Solution*

NDC 49738-050-34

AMERICAN FARE

POVIDONE-

IODINE

SOLUTION

First Aid Antiseptic
Kills germs in minor burns, cuts and scrapes

8 fl. oz. (236 mL)

*This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.

If you are not completely satisfied with this or any American Fare product, please call 1-800-842-7886.

Distributed by:

Kmart Corporation

Hoffman Estates, IL 60179

Made in USA

Other Information

Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients

citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide

Ask A Doctor in Case Of

deep or puncture wounds
animal bites
serious burns

Keep Out of Reach of Children

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

Discontinue Use and Ask A Doctor

if condition persists or gets worse
for use longer than 1 week

Structured Label Content

Use (USE)

First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Do Not (Do not)

use in the eyes
use on individuals who are allergic or sensitive to iodine
apply over large areas of the body

Warnings and Precautions (34071-1)

Section 42229-5 (42229-5)

Section 50567-7 (50567-7)

Section 50568-5 (50568-5)

Section 53413-1 (53413-1)

Section 53414-9 (53414-9)

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

For external use only.

Directions (DIRECTIONS)

Clean the affected area
Apply a small amount of this product to the area 1-3 times daily
May be covered with a sterile bandage
If bandaged, let dry first

Active Ingredient (ACTIVE INGREDIENT)

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Label Information (LABEL INFORMATION)

Compare to active ingredient of Betadine® Solution*

NDC 49738-050-34

AMERICAN FARE

POVIDONE-

IODINE

SOLUTION

First Aid Antiseptic
Kills germs in minor burns, cuts and scrapes

8 fl. oz. (236 mL)

*This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.

If you are not completely satisfied with this or any American Fare product, please call 1-800-842-7886.

Distributed by:

Kmart Corporation

Hoffman Estates, IL 60179

Made in USA

Other Information (OTHER INFORMATION)

Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients (INACTIVE INGREDIENTS)

citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide

Ask A Doctor in Case Of (Ask a doctor in case of)

deep or puncture wounds
animal bites
serious burns

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.

Discontinue Use and Ask A Doctor (Discontinue use and ask a doctor)

if condition persists or gets worse
for use longer than 1 week

Advanced Ingredient Data

[{"name": "povidone-iodine", "unii": "85H0HZU99M", "classCode": "ACTIB", "strengthNumerator": ".10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "citric acid monohydrate", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "glycerin", "unii": "PDC6A3C0OX", "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)

{"USE": "First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns", "Do not": "use in the eyes use on individuals who are allergic or sensitive to iodine apply over large areas of the body", "PURPOSE": "Antiseptic", "WARNINGS": "For external use only.", "DIRECTIONS": "Clean the affected area Apply a small amount of this product to the area 1-3 times daily May be covered with a sterile bandage If bandaged, let dry first", "ACTIVE INGREDIENT": "Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)", "LABEL INFORMATION": "Compare to active ingredient of Betadine® Solution* NDC 49738-050-34 AMERICAN FARE POVIDONE- IODINE SOLUTION First Aid Antiseptic Kills germs in minor burns, cuts and scrapes 8 fl. oz. (236 mL) *This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®. If you are not completely satisfied with this or any American Fare product, please call 1-800-842-7886. Distributed by: Kmart Corporation Hoffman Estates, IL 60179 Made in USA", "OTHER INFORMATION": "Store at room temperature 15° - 30° C (59° - 86° F)", "INACTIVE INGREDIENTS": "citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide", "Ask a doctor in case of": "deep or puncture wounds animal bites serious burns", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away.", "Discontinue use and ask a doctor": "if condition persists or gets worse for use longer than 1 week"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:02.350418 · Updated: 2026-03-14T22:52:21.082332