POVIDONE-IODINE solution

POVIDONE-IODINE by

Drug Labeling and Warnings

POVIDONE-IODINE by is a Otc medication manufactured, distributed, or labeled by James Alexander Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (each swab)

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

Purpose

Topical Antiseptic

Uses

To treat minor skin cuts and abrasions.

Warnings

For external use only.

Ask a doctor before use if you have deep or puncture wounds serious burns

Stop use and ask a doctor if  redness, irritation, swelling or pain persists or increases
                                                infection occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help immediately 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. Discard after single use.

Other Information

 Store at room temperature away from light. Keep from freezing or excessive heat.

Inactive Ingredients

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

Questions?

Call 1-908-362-9266 Monday through Friday, 9:00am - 5:00pm e.s.t.

SPL UNCLASSIFIED SECTION

DISPENSING SOLUTIONS®

JAMES ALEXANDER CORPORATION
Blairstown, NJ (908) 362-9266
Product information and MSDS available on-line at:
www.james-alexander.com

Void of Aqueous

Packaging

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46414-7777
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46414-7777-3	10 in 1 CONTAINER	02/14/1976
1		0.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 46414-7777-2	100 in 1 CONTAINER	02/14/1976
2		0.6 mL in 1 VIAL, SINGLE-USE; 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	part333A	02/14/1976

Labeler - James Alexander Corporation (040756421)

Registrant - James Alexander Corporation (040756421)

Establishment
Name	Address	ID/FEI	Business Operations
James Alexander Corporation		040756421	manufacture(46414-7777)