NOVITA BABY PETROLATUM JELLY- petrolatum jelly 
Shield Line LLC

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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Active Ingredient

White Petrolatum (99.9% w/w)

Purpose

Skin Protectant

Uses

Warnings

FOR EXTERNAL USE ONLY

When using this product

Stop use and ask a doctor if

Do not use on

Keep out of reach of children

Directions

Inactive Ingredient

Fragrance

Package Label

Principal Display and Drug Fact Panel

NOVITA BABY PETROLATUM JELLY 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-1021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52410-1021-3226 g in 1 JAR; Type 0: Not a Combination Product10/11/2016
2NDC:52410-1021-5368 g in 1 JAR; Type 0: Not a Combination Product10/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/11/2016
Labeler - Shield Line LLC (078518916)

Revised: 10/2021
Document Id: cd9f12b7-8334-d4e1-e053-2995a90ac819
Set id: 3e9cf8bf-929b-45bf-e054-00144ff8d46c
Version: 5
Effective Time: 20211005
 
Shield Line LLC