Betadine Spray
FDA Label NDC 67618-192

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Betadine (NDC 67618-192). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients

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

Purpose

First aid Antiseptic

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Warnings

For external use only

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

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • serious burns
  • animal bites

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.

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

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

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

Bottle Label (Bottle Label)

Bottle Label (Bottle Label)

* Please review the disclaimer below.