Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3dc95764-6f45-4f6e-9a4d-f08a84efd869
Route
TOPICAL
Published
Effective Date 2013-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (41 mg)
Inactive Ingredients
Ceresin Apis Cerana Worker Secretion Oleyl Alcohol Isopropyl Myristate Octyldodecanol Lanolin Stearyl Alcohol Cetyl Alcohol Light Mineral Oil Menthol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-11

Description

Petrolatum

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Petrolatum

Uses

Helps prevent and temporarily protects chapped or windburned lips.

Warnings

For external use only.

When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor if :rash or irritation develops and lasts for more than 7 days. .

Directions

Apply liberally and evenly as needed. Children under 2 years of age: ask doctor before use.

Active Ingredient

Petrolatum

Inactive Ingredients

Beeswax, Camphor, Cetyl Alcohol, Flavor, Ispropyl Myristate, Lanolin, Menthol, Methylparaben, Mineral Oil, Octyldodecanol, Oleyl Alcohol, Ozokerite, Phenol, Phenyl Trimethicone, Propylparaben, Stearyl Alcohol, Water

Keep Out of Reach of Children

If swallowed, contact a Poison Control Center.

Package/label Principal Display Panel

Structured Label Content

Uses

Helps prevent and temporarily protects chapped or windburned lips.

Purpose

Skin Protectant

Warnings

For external use only.

When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor if :rash or irritation develops and lasts for more than 7 days. .

Directions

Apply liberally and evenly as needed. Children under 2 years of age: ask doctor before use.

Active Ingredient (Active ingredient)

Petrolatum

Inactive Ingredients

Beeswax, Camphor, Cetyl Alcohol, Flavor, Ispropyl Myristate, Lanolin, Menthol, Methylparaben, Mineral Oil, Octyldodecanol, Oleyl Alcohol, Ozokerite, Phenol, Phenyl Trimethicone, Propylparaben, Stearyl Alcohol, Water

Keep Out of Reach of Children

If swallowed, contact a Poison Control Center.

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

Advanced Ingredient Data


Raw Label Data

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