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

Purpose

Skin Protectant

Description

Petrolatum


Medication Information

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.

Uses

Helps prevent and temporarily protect dry and chapped lips.

Purpose

Skin Protectant

Directions

Apply liberally and evenly. Reapply as needed.

Inactive Ingredients

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

Description

Petrolatum

Active Ingredient

Petrolatum

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

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.

Uses

Helps prevent and temporarily protect dry and chapped lips.

Purpose

Skin Protectant

Directions

Apply liberally and evenly. Reapply as needed.

Inactive Ingredients

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

Active Ingredient (Active ingredient)

Petrolatum

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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