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  5. Label Information: Betadine

FDA Label for Betadine

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine Product Label

The following document was submitted to the FDA by the labeler of this product Atlantis Consumer Healthcare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.