drug facts

drug facts
SPL v3
SPL
SPL Set ID 6ae352fa-3d4b-4720-b68b-f58b690a501f
Route
topical
Published
Effective Date 2022-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (44.0 mg) padimate o (3.00 mg)
Inactive Ingredients
microcrystalline wax lanolin ceresin carnauba wax isopropyl myristate light mineral oil

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph not final active Since 2013-03-15

Purpose

Sunscreen, Skin Protectant

Description

Padimate O, 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 windburned 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, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).

Description

Padimate O, Petrolatum

Active Ingredient

Padimate O, 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 windburned 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, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).

Active Ingredient (Active ingredient)

Padimate O, 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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