FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC- povidone-iodine swab

First Aid Only Povidone-Iodine Antiseptic by

Drug Labeling and Warnings

First Aid Only Povidone-Iodine Antiseptic by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Povidone-Iodine Solution 10%

Purpose:

Antiseptic

Use:

First aid antiseptic to help prevent skin infection.

Warnings:

For external use only.

DO NOT USE

Do not use▪ in eyes ▪ over large areas of the body ▪ if allergic to any of the ingredients

▪ longer than 1 week unless directed by a doctor.

Ask doctor before use if you have ▪ deep or puncture wounds ▪ animal bites ▪ serious burns.

Stop use and ask a doctor if ▪ conditions worsen or clear up and then recur

▪ the condition persists for more than 7 days

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions:

Open packet and wipe affected area. Apply 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first..

Other Information:

Store at room temperature..

Inactive Ingredients:

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide,

purified water, sodium hydroxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-8112(NDC:65517-0034)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
NONOXYNOL-10 (UNII: K7O76887AP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-8112-01	10 in 1 CARTON	01/07/2020
1		0.5 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0924-8112-00	0.5 mL in 1 POUCH; Type 0: Not a Combination Product	01/07/2020
3	NDC: 0924-8112-02	50 in 1 CARTON	01/07/2020
3		0.5 mL in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 0924-8112-03	100 in 1 CARTON	01/07/2020
4		0.5 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/07/2020

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-8112) , repack(0924-8112)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-8112) , repack(0924-8112)