Betadine® Spray

Betadine® Spray
SPL v11
SPL
SPL Set ID f9939dca-cd07-3200-a95b-177a771585af
Route
TOPICAL
Published
Effective Date 2023-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Monohydrate Glycerin Poloxamer 407 Potassium Iodate Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1992-04-15 Until 2026-09-30
Description

Active ingredients Povidone-iodine, 5%(0.5% available iodine)

Purpose

First aid Antiseptic

Medication Information

Purpose

First aid Antiseptic

Description

Active ingredients Povidone-iodine, 5%(0.5% available iodine)

Uses

First aidto help prevent infection in minor

  • cuts
  • scrapes
  • burns
Section 42229-5

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431

Section 50565-1

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

Section 51945-4

Betadine 3oz Spray

NDC: 67618-160-03

Warnings

For external use only

Directions
  • clean the affected area
  • spray a small amount of the product on the area 1 to 3 timesa daily
  • may be covered with sterile bandage
  • if bandaged, let dry first
Do Not Use
  • in the eyes
  • over large areas of the body
  • If you are allergic to povidone-iodine or any other ingredientsin this preparation
Drug Facts

Active ingredients

Povidone-iodine, 5%(0.5% available iodine)

Other Information

store at25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do NotFreeze

Inactive Ingredients

citric acid, disodium phosphate, glycerin,poloxamer 407, potassium iodate, purified water, sodium hydroxide

Stop Use and Ask A Doctor If
  • the condition persists or gets worse
  • you need to use this product for more than 1 week
Ask A Doctor Before Useif You Have
  • deep or puncture wounds
  • serious burns
  • animal bites

Structured Label Content

Uses

First aidto help prevent infection in minor

  • cuts
  • scrapes
  • burns
Section 42229-5 (42229-5)

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Betadine 3oz Spray

NDC: 67618-160-03

Purpose

First aid Antiseptic

Warnings

For external use only

Directions
  • clean the affected area
  • spray a small amount of the product on the area 1 to 3 timesa daily
  • may be covered with sterile bandage
  • if bandaged, let dry first
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • If you are allergic to povidone-iodine or any other ingredientsin this preparation
Drug Facts

Active ingredients

Povidone-iodine, 5%(0.5% available iodine)

Other Information (Other information)

store at25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do NotFreeze

Inactive Ingredients (Inactive ingredients)

citric acid, disodium phosphate, glycerin,poloxamer 407, potassium iodate, purified water, sodium hydroxide

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition persists or gets worse
  • you need to use this product for more than 1 week
Ask A Doctor Before Useif You Have (Ask a doctor before useif you have)
  • deep or puncture wounds
  • serious burns
  • animal bites

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.203222 · Updated: 2026-03-14T23:12:02.945870