FDA.reportPublic FDA data

Petrolatum

Manufacturer
Amerian Sales | Consumer Product Partners, LLC
Effective date
2024-09-18
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
legacy-cache
Hydrated at
2026-08-01 20:54:47

Label at a glance#

ProductPetrolatum
Active ingredientPETROLATUM
Label structure13 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

White petrolatum USP (100%)

purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites 
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last longer than 7 days or clear up and occur again withing a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

none

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY FOODHOLD U.S.A, LLC

LANDOVER, MD 20785  1-877-846-9949

Quality guaranteed or your money back.

disclaimer

SPL UNCLASSIFIED SECTION

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

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality with a caring touch

Cottontails

baby care

skin protectant

fresh scent

petroleum jelly

NET WT 13 oz (368 g)

image descriptionimage description

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-51941520-519-27

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
26a9e12c-c04c-7cc7-e063-6394a90ad68ecfd71bbf-d1e7-49e4-8882-367749c1fcff2024-11-11Warnings, Adverse reactionsExact identifier
spl set id: cfd71bbf-d1e7-49e4-8882-367749c1fcff

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.