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

Purpose

Skin Protectant

Description

Petrolatum, 45%


Medication Information

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.

Uses

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

Purpose

Skin Protectant

Directions

Apply as needed.

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).

Description

Petrolatum, 45%

Active Ingredient

Petrolatum, 45%

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

Uses

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

Purpose

Skin Protectant

Directions

Apply as needed.

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).

Active Ingredient (Active ingredient)

Petrolatum, 45%

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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