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

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]

Drug Facts

Active ingredient

Povidone-lodine 10%

Purpose

Antiseptic

Use

First aid antiseptic to help prevent skin infection

Warnings

For external use only

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 a 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 reach of children.

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

Driections

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

Pouch label

INGREDIENTS AND APPEARANCE

FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC 
povidone-iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-8113(NDC:59050-455)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
NONOXYNOL-10 (UNII: K7O76887AP)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-8113-00	5.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	06/03/2022
2	NDC: 0924-8113-01	10 in 1 CARTON	06/03/2022
2		5.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 0924-8113-02	50 in 1 CARTON	06/03/2022
3		5.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC: 0924-8113-03	100 in 1 CARTON	08/19/2024
4		5.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/03/2022

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-8113) , repack(0924-8113)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-8113) , repack(0924-8113)