PURE PETROLEUM- white petrolatum jelly 
DZA Brands 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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Petroleum Jelly
069.001/069AA

active ingredients

White Petrolatum USP (100%)

Purpose

Skin protectant

Uses

  • temporarily protects minor: cuts, scrapes, burns
  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

  • do not get into eyes

See a doctor if

condition lasts more than 7 days

Do not use

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children.

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

Directions

apply as needed

none

Dislcaimer

This product is not manufactured or distributed by Unliever, distributor of Vaseline

Adverse Reactions

Distributed by:

DZA Brands, LLC

Salisbury, NC 28147

Scarborough, ME  04074

1-866-322-2439

principal display panel

healhty

accents

100% pure

petroleum jelly

skin protectant

compare to Vaseline

NET WT 13 OZ (368 g)

image description

PURE PETROLEUM 
white petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-069-54106 g in 1 JAR; Type 0: Not a Combination Product01/05/200901/25/2023
2NDC:55316-069-27368 g in 1 JAR; Type 0: Not a Combination Product01/05/200901/25/2023
3NDC:55316-069-96213 g in 1 JAR; Type 0: Not a Combination Product01/05/200901/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/05/200901/25/2023
Labeler - DZA Brands LLC (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55316-069)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55316-069)

Revised: 1/2023
Document Id: 7630acb3-d419-4164-8306-ba0f905a4e72
Set id: a8f1942d-485f-4c9e-804d-740d53c63acf
Version: 11
Effective Time: 20230125
 
DZA Brands LLC