Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 247ac2c9-0a97-4aa5-85fd-0d75b1b55289

Route

TOPICAL

Published

Effective Date 2010-04-19

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 1985-06-21

Description

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

Purpose

Antiseptic

Medication Information

Warnings and Precautions

Purpose

Antiseptic

Description

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

Uses

Health-care antiseptic for preparation of the skin prior to surgery
First id antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.

Section 42229-5

Section 50567-7

Section 50568-5

Section 53413-1

Section 53414-9

Warnings

For external use only.

Directions

For preparation of the skin prior to surgery:

clean the area
apply to the operative site prior to surgery

As a first aid antiseptic

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

Do Not Use

in the eyes
on individuals who are allergic or sensitive to iodine
as a first aid antiseptic for longer than 1 week

Active Ingredient

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

Label Information

Cat. No. 10-8204

NDC 50730-8204-4

TRIADINE™

POVIDONE-IODINE, USP

PREP SOLUTION

10% Topical Solution

ANTISEPTIC / GERMICIDE

ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
FIRST AID ANTISEPTIC to help prevent the risk of infection in minor cuts, scrapes and burns.
For Hospital and Professional Use.

For External Use Only!

4 Fluid Ounces (118 ml)

www.triad-group.net

TRIAD GROUP, INC.

700 West North Shore Drive

Hartland, WI 53029 MADE IN USA

Other Information

store at 15° - 30° C (59° - 86° F)

Inactive Ingredients

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

Ask A Doctor in Case Of

deep or puncture wounds
animal bites
serious burns

Stop Use and Ask A Doctor

if irritation and redness develop

Keep Out of Reach of Children

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

Structured Label Content

Uses (USES)

Health-care antiseptic for preparation of the skin prior to surgery
First id antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.

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)

For preparation of the skin prior to surgery:

clean the area
apply to the operative site prior to surgery

As a first aid antiseptic

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

Do Not Use (Do not use)

in the eyes
on individuals who are allergic or sensitive to iodine
as a first aid antiseptic for longer than 1 week

Active Ingredient (ACTIVE INGREDIENT)

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

Label Information (LABEL INFORMATION)

Cat. No. 10-8204

NDC 50730-8204-4

TRIADINE™

POVIDONE-IODINE, USP

PREP SOLUTION

10% Topical Solution

ANTISEPTIC / GERMICIDE

ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
FIRST AID ANTISEPTIC to help prevent the risk of infection in minor cuts, scrapes and burns.
For Hospital and Professional Use.

For External Use Only!

4 Fluid Ounces (118 ml)

www.triad-group.net

TRIAD GROUP, INC.

700 West North Shore Drive

Hartland, WI 53029 MADE IN USA

Other Information (OTHER INFORMATION)

store at 15° - 30° C (59° - 86° F)

Inactive Ingredients (INACTIVE INGREDIENTS)

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

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

deep or puncture wounds
animal bites
serious burns

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

if irritation and redness develop

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.

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)

{"USES": "Health-care antiseptic for preparation of the skin prior to surgery First id antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.", "PURPOSE": "Antiseptic", "WARNINGS": "For external use only.", "DIRECTIONS": "For preparation of the skin prior to surgery: clean the area apply to the operative site prior to surgery As a first aid antiseptic 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", "Do not use": "in the eyes on individuals who are allergic or sensitive to iodine as a first aid antiseptic for longer than 1 week", "ACTIVE INGREDIENT": "Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)", "LABEL INFORMATION": "Cat. No. 10-8204 NDC 50730-8204-4 TRIADINE ™ POVIDONE-IODINE, USP PREP SOLUTION 10% Topical Solution ANTISEPTIC / GERMICIDE ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection. FIRST AID ANTISEPTIC to help prevent the risk of infection in minor cuts, scrapes and burns. For Hospital and Professional Use. For External Use Only! 4 Fluid Ounces (118 ml) www.triad-group.net TRIAD GROUP, INC. 700 West North Shore Drive Hartland, WI 53029 MADE IN USA", "OTHER INFORMATION": "store at 15° - 30° C (59° - 86° F)", "INACTIVE INGREDIENTS": "citric acid, glycerin, nonoxynol-8, sodium hydroxide, water", "Ask a doctor in case of": "deep or puncture wounds animal bites serious burns", "Stop use and ask a doctor": "if irritation and redness develop", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:02.368865 · Updated: 2026-03-14T22:52:21.082332