drug facts

drug facts
SPL v2
SPL
SPL Set ID 61887a52-922c-4f0c-8685-f36bd3c95b00
Route
topical
Published
Effective Date 2014-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (0.1 g)
Inactive Ingredients
citric acid monohydrate glycerin nonoxynol-8 water sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-05-01
Purpose

Antiseptic

Description

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

Medication Information

Warnings

For external use only

Uses

■ health care antiseptic for preparation of the skin prior to surgery

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

Purpose

Antiseptic

Directions

■ for preparation of the skin prior to surgery, clean the affected area, remove the swab by stick, apply to the operative site prior to surgery

■ for use as a first aid antiseptic, clean the affected area, apply a small amount of this product on the area 1-3 times daily

Other Information

■ store at room temperature:15-30C (59-86F)

Inactive Ingredients

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

Description

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

Do Not Use

■ in the eyes

■ on individuals who are allergic or sensitive to iodine

■ over large areas of the body

■ as first aid antiseptic longer than 1 week unless directed by doctor

Discontinue use

■ if irritation and redness develops

Package Label

Active Ingredient

Povidone Iodine 10% v/v

(equivalent to 1% titratable iodine)

Consult A Doctor in Case Of

■ deep puncture wounds

■ animal bites

■ serious burns

Stop Use and Ask A Doctor If

■ if the condition persist or gets worse

Keep Out of Reach of Children

If swallowed contact a doctor or Poison Control Center right away.

Structured Label Content

Warnings

For external use only

Uses

■ health care antiseptic for preparation of the skin prior to surgery

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

Purpose

Antiseptic

Directions

■ for preparation of the skin prior to surgery, clean the affected area, remove the swab by stick, apply to the operative site prior to surgery

■ for use as a first aid antiseptic, clean the affected area, apply a small amount of this product on the area 1-3 times daily

Other Information

■ store at room temperature:15-30C (59-86F)

Inactive Ingredients

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

Do Not Use (Do not use)

■ in the eyes

■ on individuals who are allergic or sensitive to iodine

■ over large areas of the body

■ as first aid antiseptic longer than 1 week unless directed by doctor

Discontinue use

■ if irritation and redness develops

Package Label

Active Ingredient

Povidone Iodine 10% v/v

(equivalent to 1% titratable iodine)

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

■ deep puncture wounds

■ animal bites

■ serious burns

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

■ if the condition persist or gets worse

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

If swallowed contact a doctor or Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:55.742522 · Updated: 2026-03-14T22:55:43.865902