White Petrolatum: Package Insert and Label Information

WHITE PETROLATUM- 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.

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
  • systems last 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 ingredients

None

Principal display panel

100% Pure Petroleum Jelly

NET WT 2.5 OZ (71 g)

image description
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WHITE PETROLATUM
white petrolatum jelly
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-960
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 1 g in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11344-960-18 71 g in 1 TUBE None
2 NDC:11344-960-27 369 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 07/15/2015
Labeler — Vi-Jon, LLC (790752542)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (11344-960)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (11344-960)

Revised: 04/2023 Vi-Jon, LLC

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