Betadine® Dry Powder Spray

Betadine® Dry Powder Spray
SPL v6
SPL
SPL Set ID 1888546e-893e-132d-72b4-d138e71a2a8c
Route
TOPICAL
Published
Effective Date 2023-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (.05 mg)
Inactive Ingredients
Isobutane Isopropyl Myristate Propane Methoxyflurane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-06-15 Until 2025-10-31

Description

Active ingredient Povidone-iodine,5% (0.5% available iodine).

Purpose

First aidantiseptic


Medication Information

Purpose

First aidantiseptic

Description

Active ingredient Povidone-iodine,5% (0.5% available iodine).

Uses

First aidto help prevent infection in minor

  • cuts
  • scrapes
  • burns
Section 42229-5

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

305653-0A

Section 50565-1

Keep out of reachof children.

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

Section 51945-4

BetadineDry Powder Spray

NDC: 67618-165-01

Warnings

Extremely Flammable Do not use near heat, flame or while smoking. Do notpuncture or incinerate. Contents under pressure. Do not store at temperaturesabove 120⁰F. Intentional misuse by deliberately concentrating andinhaling the contents can be harmful or fatal

Directions
  • Clean the affected area
  • SHAKE WELL BEFORE USE
  • Hold can approximately 6 inches from wound and apply a thinlayer over affected area 1 to 3 daily
  • May be covered with a sterile bandage
Do Not Use
  • in or near eyes
  • over large areas of the body
  • if you are allergic to povidone-iodine or any other ingredientsin this preparation
Drug Facts

Active ingredient

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

Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
Inactive Ingredients

Isobutane,isopropyl myristate, pentrane, propane

When Using This Product
  • do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor.
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 Use If 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: AvrioHealth L.P. Stamford, CT 06901-3431

305653-0A

Section 50565-1 (50565-1)

Keep out of reachof children.

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

Section 51945-4 (51945-4)

BetadineDry Powder Spray

NDC: 67618-165-01

Purpose

First aidantiseptic

Warnings

Extremely Flammable Do not use near heat, flame or while smoking. Do notpuncture or incinerate. Contents under pressure. Do not store at temperaturesabove 120⁰F. Intentional misuse by deliberately concentrating andinhaling the contents can be harmful or fatal

Directions
  • Clean the affected area
  • SHAKE WELL BEFORE USE
  • Hold can approximately 6 inches from wound and apply a thinlayer over affected area 1 to 3 daily
  • May be covered with a sterile bandage
Do Not Use (Do not use)
  • in or near eyes
  • over large areas of the body
  • if you are allergic to povidone-iodine or any other ingredientsin this preparation
Drug Facts

Active ingredient

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

Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
Inactive Ingredients (Inactive ingredients)

Isobutane,isopropyl myristate, pentrane, propane

When Using This Product (When using this product)
  • do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor.
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 Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • serious burns
  • animal bites

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)