BIOTRONIX HEALTHCARE- povidone iodine sponge 
Biotronix Healthcare Industries, 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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Active ingredient

Povidone Iodine 10%

Purpose
Antiseptic

Warnings
For external use only. Do not use in the eyes.

Stop use and ask a doctor if Skin shows symptons of irritation, sensitivity, redness, pain or swelling

Direction

Inactive ingredients

Hydroxyethylcellulose, Nonoxynol ethoxylate, Purified Water

Uses For cleansing hands and arms prior to surgery

Other information

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

image of package label

BIOTRONIX HEALTHCARE 
povidone iodine sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71389-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
NONOXYNOL-10 (UNII: K7O76887AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71389-101-0120 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)05/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/03/2018
Labeler - Biotronix Healthcare Industries, Inc. (065762392)

Revised: 5/2018
Document Id: 6b89888b-014c-5c14-e053-2991aa0a1e70
Set id: 6b59f82e-ffdc-42e7-e053-2a91aa0a13b8
Version: 2
Effective Time: 20180506
 
Biotronix Healthcare Industries, Inc.