FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES- povidone-iodine liquid

FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules by

Drug Labeling and Warnings

FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules by is a Otc medication manufactured, distributed, or labeled by The Wild Side, Llc dba Firstline Medical, James Alexander Corporation, STERIS Isomedix. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules

Active ingredient

Povidone-iodine 10%

Purpose

Antiseptic

Uses

• Patient preoperative skin preparation
• For preparation of the skin prior to surgery
• Helps to reduce bacteria that potentially can cause skin infection
  

Warnings

For external use only.

Do not use

• in the eyes
  

When using this product

keep out of eyes, ears, and mouth

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours
• infection occurs
  

Keep out of reach of children.

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

Directions

• clean the area
• reverse cardboard sleeve then crush at dot between thumb and forefinger
• allow solution to saturate tip
• apply product to the operative site prior to surgery using the applicator tip
  

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 1-866-433-2131 Monday through Friday 9:00am-5:00pm est

LINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules 25 count (

41477-420-69)

• Representative Package Labeling

INGREDIENTS AND APPEARANCE

FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES  
povidone-iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41477-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 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: 41477-420-69	25 in 1 PACKAGE
1		5 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2014

Labeler - The Wild Side, Llc dba Firstline Medical (969962864)

Registrant - The Wild Side, Llc dba Firstline Medical (969962864)

Establishment
Name	Address	ID/FEI	Business Operations
James Alexander Corporation		040756421	manufacture(41477-420)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Isomedix		933290723	manufacture(41477-420)