FIRST AID ANTISEPTIC- povidone-iodine solution

First Aid Antiseptic by

Drug Labeling and Warnings

First Aid Antiseptic by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 15º-30ºC (59º-86ºF)

inactive ingredents

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

SPL UNCLASSIFIED SECTION

*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

topcare@topco.com

050.002/050AE

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)

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-13 PARETH-9 (UNII: 9BXD858P37)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-011-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/29/2004

Labeler - Topco Associates LLC (006935977)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(36800-011)