SPL v2
SPL
SPL Set ID 17861122-2231-4a54-b3d8-894153c708d7
Route
TOPICAL
Published
Effective Date 2018-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (99.397 g)
Inactive Ingredients
Aloe Vera Leaf Vitamin A Palmitate Cholecalciferol .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-09-18

Description

Active Ingredient:                                                                                       Purpose Petrolatum USP 99%............................................................................Skin Protectant

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Active Ingredient:                                                                                       Purpose Petrolatum USP 99%............................................................................Skin Protectant

Uses

Temporarily protects minor: cuts - scrapes - burns

Temporarily protects and helps relieve chapped or cracked skin

Helps protect against the drying effects of wind and cold weather

Label

Warning

For external use only

Do not use on - deep or puncture wounds - Animals bites - Serious burns

Directions

apply as needed

Active Ingredient:

Active Ingredient:                                                                                       Purpose

Petrolatum USP 99%............................................................................Skin Protectant

Inactive Ingredients:

aloe extract, cholecalciferol (vitamin D), retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E)

When Using This Product

When using this product - do not get into eyes

Stop Use and Ask A Doctor If

Stop use and ask a doctor if - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

Temporarily protects minor: cuts - scrapes - burns

Temporarily protects and helps relieve chapped or cracked skin

Helps protect against the drying effects of wind and cold weather

Label

Purpose

Skin Protectant

Warning

For external use only

Do not use on - deep or puncture wounds - Animals bites - Serious burns

Directions

apply as needed

Active Ingredient:

Active Ingredient:                                                                                       Purpose

Petrolatum USP 99%............................................................................Skin Protectant

Inactive Ingredients: (Inactive ingredients:)

aloe extract, cholecalciferol (vitamin D), retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E)

When Using This Product (When using this product)

When using this product - do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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