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SPL v5

SPL

SPL Set ID 32b84286-471a-4d15-80fb-2f516dc1d6ea

Route

TOPICAL

Published

Effective Date 2020-12-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Petrolatum (99 g)

Inactive Ingredients

Cocoa Butter

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-12-24

Description

White Petrolatum USP (99%)

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

White Petrolatum USP (99%)

Uses

• For the temporary protection of minor cuts, scrapes, burns

• Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this productavoid contact with eyes.

Section 50570-1

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

Section 51945-4

PRINCIPAL DISPLAY PANEL

COCOA BUTTER PETROLEUM JELLY

NET WT 7.5 OZ (213 g)

Warnings

For External Use Only

Directions

apply product liberally, as often as necessary.

Active Ingredient

White Petrolatum USP (99%)

Inactive Ingredients

Theobroma Cacao (Cocoa) Seed Butter, fragrance

Structured Label Content

Uses

• For the temporary protection of minor cuts, scrapes, burns

• Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this productavoid contact with eyes.

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

COCOA BUTTER PETROLEUM JELLY

NET WT 7.5 OZ (213 g)

Purpose

Skin protectant

Warnings

For External Use Only

Directions

apply product liberally, as often as necessary.

Active Ingredient

White Petrolatum USP (99%)

Inactive Ingredients (Inactive ingredients)

Theobroma Cacao (Cocoa) Seed Butter, fragrance

Advanced Ingredient Data

[{"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "99", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "• For the temporary protection of minor cuts, scrapes, burns • Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.", "50565-1": "Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask doctor if condition worsens or does not improve within 7 days.", "50567-7": "When using this product avoid contact with eyes.", "50570-1": "Do not use on deep puncture wounds, animal bites, or serious burns. Ask a doctor.", "51945-4": "PRINCIPAL DISPLAY PANEL COCOA BUTTER PETROLEUM JELLY NET WT 7.5 OZ (213 g)", "Purpose": "Skin protectant", "Warnings": "For External Use Only", "Directions": "apply product liberally, as often as necessary.", "Active Ingredient": "White Petrolatum USP (99%)", "Inactive ingredients": "Theobroma Cacao (Cocoa) Seed Butter, fragrance"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:13.741531 · Updated: 2026-03-14T23:12:24.385926