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

----------

Private Label Povidone Iodine Gargle 0.5%

Drug Facts

Active Ingredient

Povidone-Iodine 0.5%

(0.05% available iodine)

Purpose

Antiseptic

Use

For the temporary relief of occasional sore throat.

Warnings

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and voniting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

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 gargling is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DO NOT SWALLOW

Adults and children 12 years and older:

Children under 12:

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 Gargle Label

Gargle Label 2022Gargle IFC 2022Gargle Label.jpgGargle.jpg

POVIDONE IODINE 
povidone iodine gargle 0.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9128
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:0395-9128-981 in 1 CARTON06/10/2020
1237 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00306/10/2020
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-9128) , analysis(0395-9128) , pack(0395-9128) , label(0395-9128)

Revised: 12/2023
Document Id: 0c9380d5-c284-0902-e063-6394a90ac157
Set id: a7b9ad55-cfeb-6066-e053-2a95a90af975
Version: 5
Effective Time: 20231215
 
Humco Holding Group, Inc.