Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f0d9d01e-bfdf-4e33-abfb-f683d414d808
Route
TOPICAL
Published
Effective Date 2025-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (28 ug)
Inactive Ingredients
Light Mineral Oil White Wax Microcrystalline Wax Lanolin

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-09

Description

Petrolatum, 45%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Petrolatum, 45%

Uses

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

Warnings

For external use only. Stop use and ask a doctor if rash or irritation develops and lasts. Children under 6 months of age: Ask a doctor before use.

Directions

Apply as needed.

Active Ingredient

Petrolatum, 45%

Inactive Ingredients

Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).

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

Uses

Helps prevent and temporarily protect 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. Children under 6 months of age: Ask a doctor before use.

Directions

Apply as needed.

Active Ingredient (Active ingredient)

Petrolatum, 45%

Inactive Ingredients

Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).

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


Raw Label Data

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