FDA.reportPublic FDA data

Budpak Petroleum Cocoa Butter

Manufacturer
Budpak Inc. | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2014-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:25

Label at a glance#

ProductBudpak Petroleum Cocoa Butter
Active ingredientPETROLATUM
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

White Petrolatum USP  99.9%

OTC - PURPOSE SECTION

Purpose

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 SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - STOP USE SECTION

See a doctor if condition lasts more than 7 days.

OTC - DO NOT USE SECTION

Do not use on deep or puncture wounds, animal bites, serious burns.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply as needed.

SPL UNCLASSIFIED SECTION

Other Information

Store at 20°to 25°C (68° to 77°F).

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Theobroma Cacao (Cocoa) Seed Butter,  Fragrance.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Petroleum Cocoa Butter Jelly

White Petrolatum 99.9%

NET WT 0.5 OZ (14 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of package labelimage of package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148414petrolatum 99.9 % Topical GelPSN1
1148414petrolatum 0.999 MG/MG Topical GelSCD1
1148414petrolatum 99.9 % Topical JellySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27293-029-022020-01-31C16284748780-19d75b9d0-4a2f-f424-e053-dadaa90a57ceBudpak Petroleum Cocoa Butter Jelly
27293-029-032020-01-31C16284748780-19d75b9d0-4a2f-f424-e053-dadaa90a57ceBudpak Petroleum Cocoa Butter Jelly
27293-029-042020-01-31C16284748780-19d75b9d0-4a2f-f424-e053-dadaa90a57ceBudpak Petroleum Cocoa Butter Jelly
27293-029-142020-01-31C16284748780-19d75b9d0-4a2f-f424-e053-dadaa90a57ceBudpak Petroleum Cocoa Butter Jelly
27293-029-282020-01-31C16284748780-19d75b9d0-4a2f-f424-e053-dadaa90a57ceBudpak Petroleum Cocoa Butter Jelly
27293-029-352020-01-31C16284748780-19d75b9d0-4a2f-f424-e053-dadaa90a57ceBudpak Petroleum Cocoa Butter Jelly
27293-029-422020-01-31C16284748780-19d75b9d0-4a2f-f424-e053-dadaa90a57ceBudpak Petroleum Cocoa Butter Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27293-029-02Budpak Petroleum Cocoa Butter113 g in 1 TUBEJELLY1131
27293-029-02Budpak Petroleum Cocoa Butter1 in 1 BOXJELLY11
27293-029-03Budpak Petroleum Cocoa Butter226 g in 1 TUBEJELLY2261
27293-029-03Budpak Petroleum Cocoa Butter1 in 1 BOXJELLY11
27293-029-04Budpak Petroleum Cocoa Butter453 g in 1 JARJELLY4531
27293-029-14Budpak Petroleum Cocoa Butter1 in 1 BOXJELLY11
27293-029-14Budpak Petroleum Cocoa Butter14 g in 1 TUBEJELLY141
27293-029-28Budpak Petroleum Cocoa Butter1 in 1 BOXJELLY11
27293-029-28Budpak Petroleum Cocoa Butter28 g in 1 TUBEJELLY281
27293-029-35Budpak Petroleum Cocoa Butter35 g in 1 TUBEJELLY351
27293-029-35Budpak Petroleum Cocoa Butter1 in 1 BOXJELLY11
27293-029-42Budpak Petroleum Cocoa Butter1 in 1 BOXJELLY11
27293-029-42Budpak Petroleum Cocoa Butter42 g in 1 TUBEJELLY421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27293-029BUDPAK PETROLEUM COCOA BUTTER (WHITE PETROLATUM) JELLY [BUDPAK INC. ]1Legacy NDC, 13 package rows20140217_5f9c37eb-4cb7-48c8-b273-a1fc0dbb88ee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27293-02927293-029-14, 27293-029-28, 27293-029-35, 27293-029-42, 27293-029-02, 27293-029-03, 27293-029-04

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
COCOA BUTTER512OYT1CRRIACT

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 · 1 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate

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
0db451f5-a019-431a-87db-8c5a59ba5d325f9c37eb-4cb7-48c8-b273-a1fc0dbb88ee2014-02-14WarningsExact identifier
spl id: 0db451f5-a019-431a-87db-8c5a59ba5d32
spl set id: 5f9c37eb-4cb7-48c8-b273-a1fc0dbb88ee

Reported adverse events (FAERS/openFDA)#

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