FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES  - povidone-iodine liquid 
The Wild Side, Llc dba Firstline Medical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules

FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules

Active ingredient

Povidone-iodine 10%

Purpose

Antiseptic

Uses

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

Other information

Inactive ingredients

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)

OuterLabel

InnerLabel

FlyerLabel

FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES  
povidone-iodine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41477-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41477-420-6925 in 1 PACKAGE
15 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/15/2014
Labeler - The Wild Side, Llc dba Firstline Medical (969962864)
Registrant - The Wild Side, Llc dba Firstline Medical (969962864)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander Corporation040756421manufacture(41477-420)
Establishment
NameAddressID/FEIBusiness Operations
STERIS Isomedix933290723manufacture(41477-420)

Revised: 1/2014
Document Id: dad1ae70-b04b-4a43-9001-9d0a39df9104
Set id: c2166cc2-0878-4e71-8b51-7df5046416f4
Version: 1
Effective Time: 20140115
 
The Wild Side, Llc dba Firstline Medical