MedPath

Walgreens Cocoa Butter Jelly

Walgreens Cocoa Butter Petroleum Jelly

Approved
Approval ID

32b84286-471a-4d15-80fb-2f516dc1d6ea

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 13, 2025

Manufacturers
FDA

Walgreens

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Petroleum

PRODUCT DETAILS

NDC Product Code0363-0712
Application NumberM016
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateJuly 13, 2025
Generic NamePetroleum

INGREDIENTS (2)

COCOA BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
PETROLATUMActive
Quantity: 99 g in 100 g
Code: 4T6H12BN9U
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/24/2020

PRINCIPAL DISPLAY PANEL

COCOA BUTTER PETROLEUM JELLY

NET WT 7.5 OZ (213 g)

Principal Display & Drug Fact Panel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/24/2020

Uses

• For the temporary protection of minor cuts, scrapes, burns
• Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/5/2024

Active Ingredient

White Petrolatum USP (99%)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/24/2020

Purpose

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 12/24/2020

Warnings

For External Use Only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 12/24/2020

Do not useon deep puncture wounds, animal bites, or serious burns. Ask a doctor.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 12/24/2020

When using this productavoid contact with eyes.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 12/24/2020

Stop use and ask doctorif condition worsens or does not improve within 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/24/2020

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/24/2020

Directions

apply product liberally, as often as necessary.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/24/2020

Inactive ingredients

Theobroma Cacao (Cocoa) Seed Butter, fragrance

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