FDA.reportPublic FDA data

White Petrolatum

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Effective date
2012-08-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:46:07

Label at a glance#

ProductWhite Petrolatum
Active ingredientPETROLATUM
Label structure13 sections

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP 100%

Purpose:

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Uses:

  • temporary protection of minor
  • cuts
  • scrapes
  • burns
  • sunburn
  • chafed or chapped skin
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect from wetness

WARNINGS SECTION

Warnings:

For external use only

When using this product

  • avoid contact with eyes
  • not to be applied over deep or puncture wounds, infections or lacerations

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if a rash or other allergic reaction develops

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.

DOSAGE & ADMINISTRATION SECTION

Directions:

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

SPL UNCLASSIFIED SECTION

Other information:

  • store at room temperature 15°-30°C (59°-86°F)
  • do not sure if seal is broken or missing

SPL UNCLASSIFIED SECTION

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0053-16

White Petrolatum USP

Skin Protectant

NET WT 453.6g (1 lb.)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0053-21

White Petrolatum USP

Skin Protectant

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0053-21

White
Petrolatum USP

Skin Protectant

Soothes minor skin irritations due to:
minor burns - scrapes - abrasions

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0053-45

White Petrolatum USP

Skin Protectant

NET WT 5g (approx. 5/32 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0053-45

White Petrolatum USP

Skin Protectant

This product is available as tubes at pharmacy.

1 GROSS
5g (approx. 5/32 Oz) FOILPACS®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0053-162024-07-27C16284748780-19d75b9d0-3fb2-f424-e053-dadaa90a57ceWhite Petrolatum USP
0168-0053-212024-07-27C16284748780-19d75b9d0-3fb2-f424-e053-dadaa90a57ceWhite Petrolatum USP
0168-0053-312024-07-27C16284748780-19d75b9d0-3fb2-f424-e053-dadaa90a57ceWhite Petrolatum USP
0168-0053-452024-07-27C16284748780-19d75b9d0-3fb2-f424-e053-dadaa90a57ceWhite Petrolatum USP
0168-0053-162020-01-31C16284748780-19d75b9d0-3fb2-f424-e053-dadaa90a57ceWhite Petrolatum USP
0168-0053-212020-01-31C16284748780-19d75b9d0-3fb2-f424-e053-dadaa90a57ceWhite Petrolatum USP
0168-0053-312020-01-31C16284748780-19d75b9d0-3fb2-f424-e053-dadaa90a57ceWhite Petrolatum USP
0168-0053-452020-01-31C16284748780-19d75b9d0-3fb2-f424-e053-dadaa90a57ceWhite Petrolatum USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0053-16GM - Gram0168-0053abe6e0de-c296-48ff-9fdc-02eebdf1649012013-02-13
0168-0053-21GM - Gram0168-00533d344d9d-67f5-4188-80c9-a95ef41e242b12013-02-13
0168-0053-45GM - Gram0168-00539ddc4cd6-c073-499d-b398-622b01eac60712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2

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
0168-00530168-0053-16, 0168-0053-21, 0168-0053-31, 0168-0053-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates

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
0c5e877a-4f30-4bfd-8f97-cc42acd94634b3f48081-1831-401a-b82b-c0cf3ec6697c2022-01-03WarningsExact identifier
spl set id: b3f48081-1831-401a-b82b-c0cf3ec6697c

Reported adverse events (FAERS/openFDA)#

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