FDA.reportPublic FDA data

Fisher-Price Petroleum Jelly

Manufacturer
Ashtel Studios, Inc
Effective date
2022-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:52:57

Label at a glance#

ProductFisher-Price Petroleum Jelly
Active ingredientPETROLATUM
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP (99.9%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use on ■ deep or puncture wounds, infections or lacerations ■ animal bites ■ serious burns. Ask a doctor.

When using this product avoid contact with eyes.

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions apply as needed

INACTIVE INGREDIENT SECTION

Inactive ingredient Fragrance

SPL UNCLASSIFIED SECTION

Protects minor cuts, scrapes and burns

Skin Protectant

Smart Care®

FISHER-PRICE and associated trademarks are owned by and used under license from Mattel. ©2020 Mattel. All Rights Reserved.

QUESTIONS OR COMMENTS?

1-877-274-8358 Toll Free in USA • 1-909-434-0911 International

COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

DESIGNED IN U.S.A. • MADE IN INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1302906petrolatum 99.9 % Topical OintmentPSN2
1302906petrolatum 0.999 MG/MG Topical OintmentSCD2
1302906petrolatum 99.85 % Topical OintmentSY2
1302906petrolatum 99.89 % Topical OintmentSY2
1302906petrolatum 99.9 % Topical OintmentSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-068-012024-01-30C16284748780-11030e365-55a3-111a-e063-dadaa90a10e2Fisher-price™ Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-068-01Fisher-Price Petroleum Jelly100 g in 1 BOTTLEJELLY1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-068FISHER-PRICE PETROLEUM JELLY (PETROLATUM) JELLY [ASHTEL STUDIOS, INC]2Legacy NDC, 1 package rows20230106_96a650ca-3ef6-48a8-94e5-fc6084e24910.zip

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
70108-06870108-068-01

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
bc310d1d-b3ac-4e5a-8de5-665d1fd84f1896a650ca-3ef6-48a8-94e5-fc6084e249102022-12-29WarningsExact identifier
spl id: bc310d1d-b3ac-4e5a-8de5-665d1fd84f18
spl set id: 96a650ca-3ef6-48a8-94e5-fc6084e24910

Reported adverse events (FAERS/openFDA)#

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