Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0c9d4c39-a4ba-41d6-80f5-93bf38961de4
Route
TOPICAL
Published
Effective Date 2013-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (43.75 mg)
Inactive Ingredients
White Wax Mineral Oil Microcrystalline Wax Lanolin 3-bromocamphor, (+/-)- Carnauba Wax Cocoa Butter Menthol 2-butanoyloxybenzoic Acid Phenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-12

Description

Petrolatum

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Petrolatum

Uses

Helps prevent and temporarily protect dry and chapped lips.

Warnings

For external use only: When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and consult a doctor if: condition worsens or lasts more than 7 days. Do not induce vomiting before contacting a Poison Control Center. For adults and children over 2 years of age.

Directions

Apply liberally and evenly. Reapply as needed.

Active Ingredient

Petrolatum

Inactive Ingredients

Synthetic Beeswax, Mineral Oil, Microcrystalline Wax, Lanolin, Camphor, Copernicia Cerifera (Carnauba) Wax, Menthol, Theobroma Cacao (Cocoa) Seed Butter, Salicylic Acid, Phenol, Flavor

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting a Poison Control Center.

Package/label Principal Display Panel

Structured Label Content

Uses

Helps prevent and temporarily protect dry and chapped 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 consult a doctor if: condition worsens or lasts more than 7 days. Do not induce vomiting before contacting a Poison Control Center. For adults and children over 2 years of age.

Directions

Apply liberally and evenly. Reapply as needed.

Active Ingredient (Active ingredient)

Petrolatum

Inactive Ingredients

Synthetic Beeswax, Mineral Oil, Microcrystalline Wax, Lanolin, Camphor, Copernicia Cerifera (Carnauba) Wax, Menthol, Theobroma Cacao (Cocoa) Seed Butter, Salicylic Acid, Phenol, Flavor

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting a Poison Control Center.

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

Advanced Ingredient Data


Raw Label Data

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