FDA Label for First Aid Antiseptic

View Indications, Usage & Precautions

First Aid Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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.

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)


* Please review the disclaimer below.