budpak petroleum cocoa butter jelly

SPL v1

SPL

SPL Set ID 5f9c37eb-4cb7-48c8-b273-a1fc0dbb88ee

Route

topical

Published

Effective Date 2014-02-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

petrolatum (99.9 g)

Inactive Ingredients

cocoa butter

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2014-02-14

Description

Active Ingredient White Petrolatum USP 99.9%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Active Ingredient

Active Ingredient

White Petrolatum USP 99.9%

Indications and Usage

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.

Dosage and Administration

Directions

Apply as needed.

Description

Active Ingredient White Petrolatum USP 99.9%

Section 42229-5

Other Information

Store at 20°to 25°C (68° to 77°F).

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9

See a doctor if condition lasts more than 7 days.

Section 50567-7

When using this product do not get into eyes

Section 50570-1

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

Section 51727-6

Inactive Ingredients

Theobroma Cacao (Cocoa) Seed Butter, Fragrance.

Section 51945-4

Section 55105-1

Purpose

Skin Protectant

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active Ingredient

White Petrolatum USP 99.9%

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Directions

Apply as needed.

Section 42229-5 (42229-5)

Other Information

Store at 20°to 25°C (68° to 77°F).

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

See a doctor if condition lasts more than 7 days.

Section 50567-7 (50567-7)

When using this product do not get into eyes

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients

Theobroma Cacao (Cocoa) Seed Butter, Fragrance.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "99.9", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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.", "34068-7": "Directions Apply as needed.", "34071-1": "Warnings For external use only.", "42229-5": "Other Information Store at 20°to 25°C (68° to 77°F).", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.", "50566-9": "See a doctor if condition lasts more than 7 days.", "50567-7": "When using this product do not get into eyes", "50570-1": "Do not use on deep or puncture wounds, animal bites, serious burns.", "51727-6": "Inactive Ingredients Theobroma Cacao (Cocoa) Seed Butter, Fragrance.", "55105-1": "Purpose Skin Protectant", "55106-9": "Active Ingredient White Petrolatum USP 99.9%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:44.971378 · Updated: 2026-03-14T22:53:41.456865