POVIDONE-IODINE- povidone-iodine solution 
Smiths Medical ASD, INC

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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Drug Facts

<paragraph>Povidone-Iodine <paragraph>



In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.



Antiseptic skin preparation

<paragraph>Do not use if allergic to iodine

For external use only

Ask a doctor before use if injuries are

  • deep or punture wounds
  • serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

Do not use in eyes

Avoid pooling beneath patient

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison
control center immediately.<paragraph>

Apply locally as needed

Antiseptic

<paragraph>citric acid, disodium phosphate,

nonoxynol-9, sodium hydroxide, water<paragraph>

Povidone Packet image.jpgPovidone Iodine Solution

POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51688-5473
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 Monohydrate (UNII: 2968PHW8QP)  
Sodium Phosphate, DIBASIC (UNII: GR686LBA74)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Nonoxynol-9 (UNII: 48Q180SH9T)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51688-5473-222.5 mL in 1 PACKET; Type 0: Not a Combination Product01/03/198412/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/03/198412/30/2019
Labeler - Smiths Medical ASD, INC (137835299)

Revised: 1/2020
Document Id: 2e1080c7-62cf-4813-9a90-ca9c039df97e
Set id: 389264a4-1353-4282-adcf-17b06f361409
Version: 9
Effective Time: 20200102
 
Smiths Medical ASD, INC