RASH BUSTER- zinc oxide paste paste 
Jeshurun Pharmaceutical LLC

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Inactive ingredients

inactive ingredients

Dosage and adminstration

dosage and adminstration

Precaution section

precaution

Adverse reactions

adverse reaction

Indication & usage

Indication & usage

OTC- Active ingredient

Active ingredients

Health claim

Health claim

For adult use only

Purpose

purpose

Ask doctor

ask doctor

Warnings

warnings

keep out of reach of children

LABEL AND DRUG FACTS

label and drug facts

RASH BUSTER 
zinc oxide paste paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83347-1844
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42.42 g  in 210 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM139.629 g  in 210 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN10.857 g  in 210 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL (UNII: BBL281NWFG)  
Product Characteristics
Colorwhite (White Paste) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83347-1844-1210 g in 1 JAR; Type 0: Not a Combination Product05/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/01/2023
Labeler - Jeshurun Pharmaceutical LLC (092600853)
Registrant - Jeshurun Pharmaceutical LLC (092600853)
Establishment
NameAddressID/FEIBusiness Operations
Chae Organics, LLC828138375manufacture(83347-1844)

Revised: 10/2024
Document Id: 23c7645a-4aa0-a75c-e063-6294a90a1011
Set id: f771440f-0f6f-9ff7-e053-6294a90a10f3
Version: 4
Effective Time: 20241005
 
Jeshurun Pharmaceutical LLC