Povidone Iodine by Custom Kits Company Inc / James Alexander Corporation POVIDONE IODINE swab

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Custom Kits Company Inc, James Alexander Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

10% Povidone Iodine Solution USP (1% available iodine)

Purpose

Topical Antiseptic

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply soltion to injury.

Warnings

• For External Use Only

Ask a Doctor before use if you have

Deep or puncture wounds

Serious Burns

Stop Use

redness, irritation, swelling or pain persists or increases

infection occurs

Keep Out Of Reach Of Children

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

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

Other Information

Store at room temperature away from light keep from freezing or excessive heat

Inactive Ingredient

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68183-116
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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68183-116-01	10 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	10/14/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/14/2015

Labeler - Custom Kits Company Inc (928643712)

Establishment
Name	Address	ID/FEI	Business Operations
James Alexander Corporation		040756421	manufacture(68183-116)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Kits Company Inc		928643712	repack(68183-116) , relabel(68183-116)