Betadine Spray
FDA Label NDC 67618-160

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 67618-160). 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 otc - active ingredient, otc - purpose, indications & usage, otc - do not use, otc - stop use, otc - keep out of reach of children, otc - when using, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

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

Otc - Purpose

Purpose

First aid antiseptic

Indications & Usage

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

Otc - Do Not Use

    Ask a doctor before use if you have
  • deep or puncture wounds
  • serious burns
  • animal bites

Otc - Stop Use

    Stop use and ask a doctor if
  • the condition persists or gets worse
  • you need to use this product for more than 1 week

Otc - 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.

Otc - When Using

Directions

  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times daily
  • if bandaged, let dry first

How Supplied

Other information

  • store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F). Do not freeze.

Inactive Ingredient

Inactive ingredients

citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water

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

303814-0B

©2015, Purdue Products L.P.


Package Label.Principal Display Panel

Betadine Spray
NDC: 67618-160-03

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