IYPOLY- immunoglobulin y aerosol, spray 
Whoniz

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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82462-103 IYPOLY

Purposes

Antiseptic

Active Ingredient

Immunoglobulin Y 0.15%

Citric Acid 0.01%

Propylene glycol 1%

Uses

Helps to prevent and reduce the penetration of respiratory infectious viruses.

Warnings

Limit the use when hypersensitivity reactions occur due to the ingredients contained in this product.

Warnings

Keep out of the reach of children

Warnings

Do not share the bottle for hygienic reasons and to prevent the transmission of pathogens

Warnings

Stop use if symptoms do not improve after using this product and consult a physician.

Warnings

Please store this product at room temperature. (1~30 ℃ )

Directions

Remove the protective cover and pump it a few times until it sprays evenly before the first use. Hold the body upright. Gently insert the tip of the device into the front part of the nose. Spray 1~2 times or required amount into the nose. After use, put the protective cover back on.

Inactive Ingredients

Purified water , Pentyleneglycol , Methylparaben, Trehalose, Tannicacid , Citricacid,

Sodiumcitrate, Propyleneglyco, PEG60 Hydrogenated, Casteroil , Greentea extract ,

Sodiumcarbonate , Peppermint oil

Display Panel Label

label

IYPOLY 
immunoglobulin y aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82462-103
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1 g  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.01 g  in 100 mL
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) HUMAN IMMUNOGLOBULIN G0.15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TANNIC ACID (UNII: 28F9E0DJY6)  
PEPPERMINT OIL TERPENELESS (UNII: 4CA0UO1N3Z)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TREHALOSE (UNII: B8WCK70T7I)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82462-103-0120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/23/2021
Labeler - Whoniz (695574807)

Revised: 6/2022
Document Id: e06eff3b-2588-7132-e053-2a95a90ae08b
Set id: d3c7bf84-7b46-7418-e053-2a95a90a7b82
Version: 2
Effective Time: 20220601
 
Whoniz