FDA.reportPublic FDA data

Personal CARE

Manufacturer
Delta Brands & Products LLC
Effective date
2018-11-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:47:53

Label at a glance#

ProductPersonal CARE Cocoa Butter
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

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

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum (30%)

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days

Do not use on

OTC - DO NOT USE SECTION

■ deep or puncture wounds ■ animal bites ■ serious burns

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

water (aqua), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl stearate, fragrance, ploysorbate-80, laureth-20, BHT, methyparaben,propylparaben, dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72133-121-452021-07-23C16284748780-1c7ccaba7-27d2-fd44-e053-dadaa90aa01bDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72133-121PERSONAL CARE COCOA BUTTER (WHITE PETROLATUM) CREAM [DELTA BRANDS & PRODUCTS LLC]2Legacy NDC20181103_69972fb1-5482-a718-e053-2a91aa0ac602.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72133-12172133-121-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL STEARATE SEFCZ5MH785IIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCOA BUTTER512OYT1CRRIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYSORBATE 806OZP39ZG8HIACT
LAURETH-206SU0SC83AHIACT
PETROLATUM4T6H12BN9UACTIB
DIMETHICONE92RU3N3Y1OIACT

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
79b67bee-e229-8d9c-e053-2991aa0a6b8b69972fb1-5482-a718-e053-2a91aa0ac6022018-11-02WarningsExact identifier
spl id: 79b67bee-e229-8d9c-e053-2991aa0a6b8b
spl set id: 69972fb1-5482-a718-e053-2a91aa0ac602

Reported adverse events (FAERS/openFDA)#

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