SPL v3
SPL
SPL Set ID 201545b8-0697-5601-e063-6394a90a12f4
Route
TOPICAL
Published
Effective Date 2024-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-20
Description

Available Iodine

Medication Information

Warnings and Precautions

*For extemal use only.

*Flammable. keep away from fire or flame.

Indications and Usage

For preparation of the skin prior to an injection and to decrease germs in minor cuts and scrapes.

Dosage and Administration

For preparation of the skin prior to an injection and to decrease germs in minor cuts and scrapes.One piece at a time.

Description

Available Iodine

Section 44425-7

Store at room temperature.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

*Stop use if irritation and redness develop. If condition persists consult your health care practioner.

*Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

Do not use " with electrocautery procedures " in the eyes. lf contact occurs, flush eyes with water.

Section 51727-6

water

Section 51945-4

Section 55105-1

disinfect

Section 55106-9

Available Iodine

Structured Label Content

Indications and Usage (34067-9)

For preparation of the skin prior to an injection and to decrease germs in minor cuts and scrapes.

Dosage and Administration (34068-7)

For preparation of the skin prior to an injection and to decrease germs in minor cuts and scrapes.One piece at a time.

Warnings and Precautions (34071-1)

*For extemal use only.

*Flammable. keep away from fire or flame.

Section 44425-7 (44425-7)

Store at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

*Stop use if irritation and redness develop. If condition persists consult your health care practioner.

*Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do not use " with electrocautery procedures " in the eyes. lf contact occurs, flush eyes with water.

Section 51727-6 (51727-6)

water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

disinfect

Section 55106-9 (55106-9)

Available Iodine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:04.854030 · Updated: 2026-03-14T23:12:14.139281