FDA.reportPublic FDA data

Royal Creamy Petroleum Jelly

Manufacturer
Mission Series Inc. dba Prestige Beauty Care
Effective date
2022-06-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:53

Label at a glance#

ProductRoyal Creamy Petroleum Jelly
Active ingredientPETROLATUM
Label structure11 sections

Dosage and administration

Directions: Apply as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Petrolatum 30%

Purpose

OTC - PURPOSE SECTION

Purpose Skin Protectant

Indications & Usage

INDICATIONS & USAGE SECTION

Uses:

Temporarily protects minor cuts, scrapes, and burns.

Temporarily protects and helps relieve chapped or cracked skin.

Helps protect from the drying effects of wind and cold weather.

Warnings

WARNINGS SECTION


Warnings:

For external use only. Do not use on deep wounds.

When using this product do not get into eyes.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Apply as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Water (Aqua), Mineral Oil, Stearic Acid, Glyceryl Monostearate, Cetearyl Alcohol, CM 1000, Fragrance, Triethanolamine, Carbopol 940, Methyl Paraben, Propyl Paraben, Sodium Lauryl Sulphate, Vitamin E.

SPL UNCLASSIFIED SECTION

Made in India

DISTRIBUTED BY:

PRESTIGE BEAUTY CARE

1585 West Mission Blvd.

Pomona, CA 91766

*This product is not manufactured or distributed by Unilever, distributor of the registered trademark Vaseline (r)

SPL UNCLASSIFIED SECTION

Creamy Petroleum Jelly is specially formulated to moisturize, soften and sooth dry skin. Blended with Vitamin E to produce a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Royal Petroleum JellyRoyal Petroleum Jelly

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037285petrolatum 30 % Topical GelPSN3
1037285petrolatum 0.3 MG/MG Topical GelSCD3
1037285petrolatum 30 % Topical GelSY3
1037285petrolatum 30 % Topical JellySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73597-001-072024-01-30C16284748780-1d6a99b39-badc-a426-e053-dadaa90af4c2Royal Creamy Petroleum Jelly
73597-001-072022-06-08C16284748780-1d6a99b39-badc-a426-e053-dadaa90af4c2Royal Creamy Petroleum Jelly
73597-001-072022-01-28C16284748780-1d6a99b39-badc-a426-e053-dadaa90af4c2Royal Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73597-001-07Royal Creamy Petroleum Jelly198 g in 1 TUBEJELLY1983

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73597-001ROYAL CREAMY PETROLEUM JELLY (PETROLATUM JELLY) JELLY [MISSION SERIES INC. DBA PRESTIGE BEAUTY CARE]3Legacy NDC, 1 package rows20220623_9dd9a08b-68ee-323d-e053-2a95a90aa372.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73597-00173597-001-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CETETH-20I835H2IHHXIACT
MINERAL OILT5L8T28FGPIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
METHYLPARABENA2I8C7HI9TIACT
PETROLATUM4T6H12BN9UACTIB
WATER059QF0KO0RIACT

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
e1851eeb-5315-344b-e053-2995a90ae7499dd9a08b-68ee-323d-e053-2a95a90aa3722022-06-15WarningsExact identifier
spl id: e1851eeb-5315-344b-e053-2995a90ae749
spl set id: 9dd9a08b-68ee-323d-e053-2a95a90aa372

Reported adverse events (FAERS/openFDA)#

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