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 Dolgencorp LLC, Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

First aid antiseptic

Use

first aid to help prevent the risk of infection in

• minor cuts
• scrapes
• burns

Warnings

For external use only

Do not use

• in the eyes or apply over large areas of the body
• longer than 1 week unless directed by a doctor

ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns

stop use and ask a doctor if

• conditrion persists or gets worse

Keep out of reach of children

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

Directions

• apply aclean the affected area
• 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 information

• store between 15º-30ºC (59º-86ºF)

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Visit us at: Rexall.com or call 1-864-REXALL

PACKAGED FOR DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

050.002/050AE

Principal Display Panel

Since 1903

REXALL

Topical Antiseptic

Microbicide

Povidone Iodine Solution, 10%

kills germs in minor burns, cust and scrapes

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-001
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: 55910-001-26	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/11/2012

Labeler - Dolgencorp LLC (068331990)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(55910-001)