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NDC 36800-0519-27 Petroleum 1 g/g Details

Petroleum 1 g/g

Petroleum is a TOPICAL JELLY in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates, LLC. The primary component is PETROLATUM.

Product Information

NDC	36800-0519
Product ID	36800-519_12471777-fc9a-4a07-8e71-2575c1c28c92
Associated GPIs	98600040004200
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Petroleum
Proprietary Name Suffix	n/a
Non-Proprietary Name	White Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	JELLY
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/g
Substance Name	PETROLATUM
Labeler Name	Topco Associates, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0519-27 (36800051927)

Pricing Information	N/A
NDC Package Code	36800-519-27
Billing NDC	36800051927
Package	368 g in 1 JAR (36800-519-27)
Marketing Start Date	1990-11-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cd7f1727-0b6e-4993-9820-43783994efa1 Details

Active ingredients

White Petrolatum USP (100%)

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash
protects chafed skin due to diaper rash
helps seal out wetness

Warnings

For external use only

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product

do not get into eyes

Stop use and ask a doctor

if condition worsens or does not improve within 7 days or clear up and occur again in a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

change wet and soilded diapers promptly
cleanse the diaper area, and allow to dry
apply product liberally as often as necessary, with each diaper change, and expecially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredient

none

Disclaimer

This product is not manufactured or distributed by Unilever, distributer of Vaseline Baby Petroleum Jelly Baby Fresh

principal display panel

NDC 36800-519-27

tippy

toes

baby

petroleum

jelly

skin protectant

helps treat &

prevent diaper rash

baby fresh scent

*COMPARE TO VASELINE BABY

NET WT 13 OZ (368 g)

INGREDIENTS AND APPEARANCE

PETROLEUM

white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-519
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-519-27	368 g in 1 JAR; Type 0: Not a Combination Product	11/15/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/15/1990

Labeler - Topco Associates, LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-519)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-519)

Revised: 6/2022

Document Id: 12471777-fc9a-4a07-8e71-2575c1c28c92

Set id: cd7f1727-0b6e-4993-9820-43783994efa1

Version: 14

Effective Time: 20220609