POVIDONE-IODINE PREP PAD- povidone-iodine swab 
Hubei Chenteng Healthcare Co.,Ltd.

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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Povidone-Iodine Prep Pad

Active ingredient:

Povidone-Iodine 10%w/w

(1% titratable iodine)

Purpose:

Antiseptic

Use

To help prevent infection in minor cuts and scrapes.

Warnings:

  • For external use only
  • Single use only
    Do not use:
  • in the eyes
  • over large areas of the body
  • as a first aid antiseptic for longer than one week unless directed by a physician
  • on individuals who are sensitive or allergic to iodine
  • if the package is damaged or open
  • Consult a physician in case of:
  •  puncture or deep wounds
  • serious burns
  • animal bites

Directions for use:

  • Clean the treatment area
  • Apply to the treatment area or operative site before surgery

Keep out of reach of children.

Inactive Ingredient

Purified water

Package Label

Package label

POVIDONE-IODINE PREP PAD 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71509-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71509-001-001 in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/22/201704/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/201704/30/2022
Labeler - Hubei Chenteng Healthcare Co.,Ltd. (544504326)

Revised: 5/2019
Document Id: 8a097fe1-3a64-425e-e053-2995a90ac4b5
Set id: 2817711c-d1b6-444d-ad6d-9ff478e7ee65
Version: 2
Effective Time: 20190529
 
Hubei Chenteng Healthcare Co.,Ltd.