Betadine® Spray

Betadine® Spray
SPL v1
SPL
SPL Set ID 00002127-02bc-4c66-b0c3-ca29d8224afc
Route
TOPICAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (5 mg)
Inactive Ingredients
C12-15 Pareth-9 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-02

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 aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns
Warnings

For external use only

Directions
  • clean the affected area
  • spray a small amount of the product on the area 1 to 3 times daily
  • may be covered with a 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 ingredients in this preparation
Drug Facts

Active ingredients

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

Other Information
  • store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do Not Freeze
Inactive Ingredients

pareth 25-9, purified water, sodium hydroxide

Questions?

1-833-288-2684

Stop Use and Ask A Doctor If
  • the condition persists or gets worse
  • you need to use this product for more than 1 week
Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • serious burns
  • animal bites
Package Label.principal Display Panel

NEW LOOK!



HOSPITAL

TRUSTED

SINCE

1955



BETADINE ®

ANTISEPTIC



5% POVIDONE-IODINE



First Aid

Antiseptic Spray



√ Ideal for Minor Cuts, Wounds, Scrapes & Burns



√ Kills 99.9% of Germs* To Prevent Infection



√ Works in Secondst



√ No Stinging or Burning



3 fl oz (88.7mL)

Helps protect

against skin

infection



Golden brown

color indicates

area treated



Visit

www.Betadine.com

for more information



*commonlly associated with skin infections.

tbased on in vitro lab data.



Dist. by: Atlantis

Consumer

Healthcare Inc.

Bridgewater, NJ

08807 USA



©2024 Atlantis

Consumer

Healthcare Inc.

Betadine is a 

registered trademark

of Atlantis

Consumer

Healthcare Inc.



A0324


Structured Label Content

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns
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 times daily
  • may be covered with a 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 ingredients in this preparation
Drug Facts

Active ingredients

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

Other Information (Other information)
  • store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do Not Freeze
Inactive Ingredients (Inactive ingredients)

pareth 25-9, purified water, sodium hydroxide

Questions?

1-833-288-2684

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
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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • serious burns
  • animal bites
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NEW LOOK!



HOSPITAL

TRUSTED

SINCE

1955



BETADINE ®

ANTISEPTIC



5% POVIDONE-IODINE



First Aid

Antiseptic Spray



√ Ideal for Minor Cuts, Wounds, Scrapes & Burns



√ Kills 99.9% of Germs* To Prevent Infection



√ Works in Secondst



√ No Stinging or Burning



3 fl oz (88.7mL)

Helps protect

against skin

infection



Golden brown

color indicates

area treated



Visit

www.Betadine.com

for more information



*commonlly associated with skin infections.

tbased on in vitro lab data.



Dist. by: Atlantis

Consumer

Healthcare Inc.

Bridgewater, NJ

08807 USA



©2024 Atlantis

Consumer

Healthcare Inc.

Betadine is a 

registered trademark

of Atlantis

Consumer

Healthcare Inc.



A0324


Advanced Ingredient Data


Raw Label Data

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