Label: POVIDONE-IODINE SOLUTION- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 26, 2014

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  • Active Ingredient

    POVIDONE-IODINE USP 10% 

    Purpose

    Antiseptic

  • Warnings

    Do not use if allergic to iodine.

    For External use only.

    Ask a doctor before use if injuries are 

    --Deep or puncture wounds

    --serious bums 

    stop use ask a doctor if 

    --reness ,irritation ,swelling or pain persists or increases

    --infection occurs

    Do not use in eyes

    Avoid "pooling "benesth patient.Prolonged exposure to wet solution may cause skin irrtation.

    Keep out of reach of children.

    Keep out of reach of children.in case of axxidental ingestion,seek professional assistance or consult a poison control center immediately.

  • Directions

    Apple locally as needed.

  • Other information

    --1% titrarabil iodine --latex free ---for hospital or professional use only

    Use

    Antiseptic skin preparation

  • Inactive Ingredients

    citric acid,disodium,phosphate,nonoxynol-9,sodium hydrexide,Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE SOLUTION 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58488-006
    Route of AdministrationPERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.01 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58488-006-011201 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/20/2014
    Labeler - Tongzhou Ruihong Medical Products Factory (421312726)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tongzhou Ruihong Medical Products Factory421312726manufacture(58488-006)
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