POVIDONE IODINE- povidone-iodine spray 5% liquid 
Humco Holding Group, Inc.

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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 DrugM00301/23/2020
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: 12/2023
Document Id: 0c9368f8-3986-07dd-e063-6394a90ac66a
Set id: a7bb80c4-bbc0-21ea-e053-2995a90a52c1
Version: 4
Effective Time: 20231215
 
Humco Holding Group, Inc.