RASH BUSTER- zinc oxide paste paste 
Jeshurun Pharmaceutical LLC

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Use in the specific population

adult use

Inactive ingredients

Inactive ingredients

Dosage and adminstration

adminstration

Precaution section

precaution

Adverse reactions

Adverse reaction

Indication & usage

indication usage

OTC- Active ingredient

Active ingredients

Health claim

health claim

Keep out of children

keep out of children

Purpose

Purpose

Ask doctor

Ask doctor

Warnings

warning

LABEL AND DRUG FACTS

Principal displayRash buster label

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: 11/2023
Document Id: 0a7adae9-2f84-f74f-e063-6294a90a4533
Set id: f771440f-0f6f-9ff7-e053-6294a90a10f3
Version: 3
Effective Time: 20231118
 
Jeshurun Pharmaceutical LLC