1201, 1202

1201, 1202

Drug Labeling and Warnings

Drug Details

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POVIDINE IODINE- povidine iodine swab 
Dynarex Corporation

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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1201, 1202

Section Text

Active Ingredient                                                        Purpose

Povidone Iodine 10% w/v (9.85% w/w/)                        Antiseptic                          

Purpose:


Purpose:

  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infections.

Warnings:

Section Text

  • FOR EXTERNAL USE ONLY

Do not use:


  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Ask a doctor before use if you have:


  • Deep puncture wounds
  • Animal bites
  • Serious burns

Stop Use:


  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.


Directions Povidone iodine:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.

For preoperative patient skin preparation

  • clean area
  • apply to operative site prior to surgery using the applicator


Other information:

Store at room temperature.

Avoid excessive heat

For use as an

  • first aid antiseptic
  • pre-operative skin preperation

Inactive Ingredients

Inactive ingredients: Citric acid, glycerin, polysorbate 80, sodium citrate USP, sodium phosphate dibasic, water

Principal Display Panel

Principal Display Panel

Povidone Iodine Swabsticks 1201 & 1202

PVP 419.jpg

Povidone iodine

POVIDINE IODINE 
povidine iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67777-419
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67777-419-010.3 mL in 1 PACKET; Type 0: Not a Combination Product09/13/2016
2NDC: 67777-419-020.9 mL in 1 PACKET; Type 0: Not a Combination Product09/13/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/13/2016
Labeler - Dynarex Corporation (008124539)

Revised: 6/2018
 
Dynarex Corporation


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