PETROLEUM- white petrolatum jelly 
Vi-Jon, 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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Mountain Falls  519.001  519AD
Baby Petroleum Jelly

Active ingredient

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
  • symptoms longer than 7 days or clear up and occur again within 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 soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply product liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredient

fragrance

principal display panel

Petroleum Jelly

NET WT. 13 OZ (368 g)

image description

PETROLEUM 
white petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-519
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11344-519-1870 g in 1 JAR; Type 0: Not a Combination Product05/12/2009
2NDC:11344-519-96212 g in 1 JAR; Type 0: Not a Combination Product05/12/2009
3NDC:11344-519-27368 g in 1 JAR; Type 0: Not a Combination Product05/12/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/12/2009
Labeler - Vi-Jon, LLC (150931459)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(11344-519)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(11344-519)

Revised: 9/2021
Document Id: 540164ee-8c40-4fc2-857c-4aa42236fa04
Set id: 3dd47d9d-ecd2-4d5c-b2b3-3402ce06df3c
Version: 12
Effective Time: 20210901
 
Vi-Jon, LLC