First Aid Antiseptic Solution
FDA Label NDC 36800-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product First Aid Antiseptic (NDC 36800-011). 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 active ingredient, purpose, use, warnings, ask a doctor before use if you have, when using this product, 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

Active Ingredient

Povidone-iodine, 10% 
(equivalent to 1% available iodine)

Purpose

First aid antiseptic

Use

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings

For external use only

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animals bites
  • serious burns

When Using This Product

  • do not get into eyes or apply over large areas of the body.
  • do not use longer than 1 week unless directed by a doctor

Stop Use And Ask A Doctor If

  •  condition persists or gets worse

Keep Out Of Reach Of Children.

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

Directions

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage. 
  • if bandaged, let dry first.

Other Inforamation

  •  store between 15°-30°C (59°-86°F)

Inactive Ingredents

C12-13 Pareth-9, citric acid, disodium phosphate, glycerin, sodium hydroxide, water

Other

*This product is not manufactured or distributed by Purdue Products LP., distributor of Betadine Solution Povidone-Iodine 10%

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

TOPCO VIJ613

QUESTIONS? 1-888-423-0139

[email protected]

Principal Display Panel

TopCare

Povidone-Iodine Solution, 10%

FIRST AID ANTISEPTIC

  • Kills germs in minor burns, cuts and scrapes

    • Compare to Betadine Solution active ingredient*

    8 FL OZ (237 mL)

    Image Description (Mm3)

    Image Description (Mm3)

* Please review the disclaimer below.