POVIDONE IODINE- povidone iodine oral rinse 0.5% liquid 
Humco Holding Group, Inc.

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Private Label Povidone Iodine Oral Rinse 0.5%

Drug Facts

Active Ingredient

Povidone-Iodine 0.5%

(0.05% available iodine)

Purpose

Oral Antiseptic

Use

For preparation of the oral mucosa prior to injection, dental surgery or tooth extraction.

Warnings

Do not use this product

Stop use and consult a doctor if

Symptoms do not improve in 7 days.

Irritation, pain or redness persists or worsens.

Swelling, rash or fever develops.

When using this product do not

Get into eyes. If contact occurs, rinse eyes thoroughly with water. If iritation persists, consult a doctor.

Swallow.

Use with hydrogen peroxide.

Keep out of reach of children.

In case more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive Ingredients

Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide.

Do not use this product

If pregnant or breast-feeding

Ask a health professional before use.

Purdue Oral Rinse Label

Betadine 20 mLOral Rinse.jpg

POVIDONE IODINE 
povidone iodine oral rinse 0.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9136
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEPPERMINT (UNII: V95R5KMY2B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9136-98237 mL in 1 CONTAINER; Type 0: Not a Combination Product01/06/2021
2NDC:0395-9136-2320 mL in 1 CONTAINER; Type 0: Not a Combination Product10/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/06/2021
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-9136) , analysis(0395-9136) , pack(0395-9136) , label(0395-9136)

Revised: 12/2023
Document Id: 0c93bae9-c6ed-1fc7-e063-6394a90adea9
Set id: b83dbdd1-ff63-caf8-e053-2a95a90a5764
Version: 4
Effective Time: 20231215
 
Humco Holding Group, Inc.