FDA.reportPublic FDA data

XtraCare Creamy Petroleum Jelly

Manufacturer
Rejoice International | China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2024-02-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:07

Label at a glance#

ProductXtraCare Creamy Petroleum Jelly Cocoa Butter Enriched
Active ingredientPETROLATUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:                               Purpose

Petrolatum 30% ........................ Skin Protectant

OTC - PURPOSE SECTION

XtraCare Creamy Petroleum Jelly

Cocoa Butter enriched

Skin Protector

Dry Skin Relief Rich Creamy Moisturizer

*Compare to the active ingredient in Vaseline ® Petroleum Jelly Cream

Net Wt 7oz (198g)

XtraCare®

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

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.

INDICATIONS & USAGE SECTION

Uses

  • temporarily protects minor cuts, scrapes, burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather

WARNINGS SECTION

Warnings

For external use only

When using this product do not get into eyes.

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

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

DOSAGE & ADMINISTRATION SECTION

Directions apply as needed.

INACTIVE INGREDIENT SECTION

Inactive ingredients: water, carbomer, stearic acid, mineral oil, cetyl alcohol, glycerin, ceteareth-20, glyceryl monostearate, methylparaben, propylparaben, DMDM hydantoin, triethanolamine, disodium EDTA, theobroma cacao (cocoa) seed butter, fragrance, fd&c yellow no.5, d&c red no.33

OTHER SAFETY INFORMATION

Other Information store at room temperature.

Questions/Comments? 1-855-345-5575

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

DISTRIBUTED BY:

REJOICE INTERNATIONAL, INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043075petrolatum 30 % Topical CreamPSN3
1043075petrolatum 300 MG/ML Topical CreamSCD3
1043075petrolatum 30 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-039-012024-02-28C16284748780-11030e364-fc5c-111a-e063-dadaa90a10e2XtraCare Creamy Petroleum Jelly
57337-039-012024-01-30C16284748780-11030e364-fc5c-111a-e063-dadaa90a10e2XtraCare Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-039-01XtraCare Creamy Petroleum JellyCocoa Butter Enriched198 g in 1 BOTTLECREAM1983

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-039XTRACARE CREAMY PETROLEUM JELLY COCOA BUTTER ENRICHED (PETROLEUM) CREAM [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_580d76ee-ea89-426e-bd25-7a58481e9795.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-03957337-039-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
STEARIC ACID4ELV7Z65APIACT
MINERAL OILT5L8T28FGPIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DMDM HYDANTOINBYR0546TOWIACT
TROLAMINE9O3K93S3TKIACT
EDETATE DISODIUM7FLD91C86KIACT
COCOA BUTTER512OYT1CRRIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
PETROLATUM4T6H12BN9UACTIB

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 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route
6 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route
6 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYCREAM / TOPICAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYCREAM / TOPICAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 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
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
ndc (package): 57337-039-01
ndc (product): 57337-039
ndc11 (package): 57337003901
spl id: 126cbd70-eeab-14b6-e063-6294a90a00ac
spl set id: 580d76ee-ea89-426e-bd25-7a58481e9795

Reported adverse events (FAERS/openFDA)#

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