POVIDONE IODINE- povidone-iodine spray 5% liquid 
Humco Holding Group, 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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Private Label Povidone Iodine Spray 5%

Active Ingredient

Povidone-Iodine 5%

(0.5% available iodine)

Warnings

For external use only.

Do not use:

Ask a doctor before use if you have:

Stop and ask a doctor if:

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

Store at 25°C (77°F); Excursions permitted between 15-30°C (59-86°F). Do not freeze.

Inactive ingredients:

citric acid, disodium phosphate, glycerin, poloxamer 407, potassium iodata, purified water, sodium hydroxide.

Directions:

Uses

First aid to help prevent infection in minor

Purpose

Antiseptic

Drug Facts

Principal Display Panel

Betadine Spray 12-30-22Purdue Betadine Spray.jpg

POVIDONE IODINE 
povidone-iodine spray 5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM IODATE (UNII: I139E44NHL)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9129-9389 mL in 1 CONTAINER; Type 0: Not a Combination Product01/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/23/2020
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-9129) , pack(0395-9129) , label(0395-9129) , analysis(0395-9129)

Revised: 12/2022
Document Id: f10cda41-ad37-1cca-e053-2a95a90a60e0
Set id: a7bb80c4-bbc0-21ea-e053-2995a90a52c1
Version: 3
Effective Time: 20221230
 
Humco Holding Group, Inc.