drug facts

drug facts

SPL v5

SPL

SPL Set ID c81cd9f7-f23a-4873-8542-1926497d39ce

Route

topical

Published

Effective Date 2015-01-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

petrolatum (30.0 mg)

Inactive Ingredients

light mineral oil microcrystalline wax ceresin

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug active Since 2015-01-02

Purpose

Skin Protectant

Description

Petrolatum

Medication Information

Warnings

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days.

When using this product: avoid contact with eyes. Rinse with water to remove.

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

Uses

Helps prevent and temporarily protects dry, chapped or windburned lips.

Purpose

Skin Protectant

Directions

Apply liberally and evenly as needed. Reapply as needed.

Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Mineral Oil, Ozokerite, Microcrystalline Wax, Flavor, Cereson, Tocopherol.

Description

Petrolatum

Active Ingredient

Petrolatum

Keep Out of Reach of Children

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

Package/label Principal Display Panel

Structured Label Content

Warnings

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days.

When using this product: avoid contact with eyes. Rinse with water to remove.

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

Uses

Helps prevent and temporarily protects dry, chapped or windburned lips.

Purpose

Skin Protectant

Directions

Apply liberally and evenly as needed. Reapply as needed.

Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Mineral Oil, Ozokerite, Microcrystalline Wax, Flavor, Cereson, Tocopherol.

Active Ingredient (Active ingredient)

Petrolatum

Keep Out of Reach of Children

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "30.0", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "39", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "3.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "24", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent and temporarily protects dry, chapped or windburned lips.", "Purpose": "Skin Protectant", "Warnings": "For external use only Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days. When using this product: avoid contact with eyes. Rinse with water to remove. Keep out of reach of children: If swallowed get medical help or contact a Poison Control Center right away.", "Directions": "Apply liberally and evenly as needed. Reapply as needed. Children under 6 months of age: Ask a doctor before use.", "Active ingredient": "Petrolatum", "Inactive Ingredients": "Mineral Oil, Ozokerite, Microcrystalline Wax, Flavor, Cereson, Tocopherol.", "Keep Out of Reach of Children": "If swallowed get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:41.626597 · Updated: 2026-03-14T23:07:53.934759