drug facts

drug facts
SPL v1
SPL
SPL Set ID c8d6a93f-942b-4441-909c-0325bcbec4f5
Route
topical
Published
Effective Date 2013-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (44.0 mg) padimate o (23.50 mg)
Inactive Ingredients
light mineral oil microcrystalline wax lanolin ceresin carnauba wax isopropyl myristate

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph final active Since 2013-03-15

Purpose

Sunscreen, Skin Protectant

Description

Padimate O, White Petrolatum


Medication Information

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts.

Uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped, or wind burned lips.

Purpose

Sunscreen, Skin Protectant

Directions

Apply liberally before sun exposure and as needed.

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

Inactive Ingredients

Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Camphor, Red 6 Lake (CI 15850), Methylparaben

Description

Padimate O, White Petrolatum

Active Ingredient

Padimate O, White Petrolatum

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

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts.

Uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped, or wind burned lips.

Purpose

Sunscreen, Skin Protectant

Directions

Apply liberally before sun exposure and as needed.

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

Inactive Ingredients

Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Camphor, Red 6 Lake (CI 15850), Methylparaben

Active Ingredient (Active ingredient)

Padimate O, White Petrolatum

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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