POVIDONE-IODINE- povidone-iodine solution 
Medline Industries, LP

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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938 ReadyScrub PVP

Active ingredient

Povidone-Iodine 7.5%

(equivalent to 0.75% available iodine)

Purpose

Antiseptic

Uses

Warnings

For external use only

Do not use

  • in the eyes
  • if you are allergic to iodine or any of the other ingredients in the product

When using this product

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient

Stop use and ask a doctor

  • if irritation and redness develop
  • if condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison control center right away.

Directions

Other information

Inactive ingredients

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufactuing Information

Manufactured by:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS093947

V1 RB22DYN

Package Label

PDP

POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-938
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
NONOXYNOL-5 (UNII: ED8J5T817W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-938-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
2NDC:53329-938-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
3NDC:53329-938-23946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
4NDC:53329-938-253785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
5NDC:53329-938-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2007
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 3/2022
Document Id: da31f307-36ba-3dff-e053-2995a90a083a
Set id: 2b95078e-2caf-7005-e054-00144ff88e88
Version: 6
Effective Time: 20220314
 
Medline Industries, LP