POVIDONE-IODINE PREP- povidone-iodine swab

Povidone-Iodine Prep by

Drug Labeling and Warnings

Povidone-Iodine Prep 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 Ingredients

Povidone Iodine 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 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

Package Labeling:

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-8111(NDC: 59050-060)
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 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-8111-01	0.5 g in 1 POUCH; Type 0: Not a Combination Product	05/09/2018	10/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/14/2018	10/30/2020

Labeler - Acme United Corporation (001180207)

Registrant - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-8111) , repack(0924-8111)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-8111) , repack(0924-8111)