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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-0712
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Petroleum
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 13, 2025
FDA Product Classification

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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Walgreens Cocoa Butter Jelly - FDA Drug Approval Details