SPL v2
SPL
SPL Set ID 21bdbb13-cc64-b5d7-e063-6294a90ae3fd
Route
TOPICAL
Published
Effective Date 2024-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (41 g)
Inactive Ingredients
Mineral Oil Glycerin Ceresin Lanolin Levomenol Panthenol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-11

Description

Petrolatun 41%

Purpose

Skin Protectant (Ointment)


Medication Information

Purpose



Skin Protectant (Ointment)

Description

Petrolatun 41%

Use



temporarily protects and helps relieve chapped or cracked skin

helps protect from the drying effects of wind and cold weather

Section 51945-4

Warnings

For external use only

Directions



Apply as needed.

Do Not Use On



deep or puncture wounds

animal bites

serious burns

Active Ingredient

Petrolatun 41%

Inactive Ingredients



Mineral Oil

Ceresin

Lanolin

Bisabolol

Glycerin

Panthenol

When Using This Product



When using this product do not get into eyes.

Stop Use and Ask A Doctor If



condition worsens

symptoms last more than 7days or clear up and occur again within a few days.

Keep Out of Reach of Children



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


Structured Label Content

Use



temporarily protects and helps relieve chapped or cracked skin

helps protect from the drying effects of wind and cold weather

Section 51945-4 (51945-4)

Purpose



Skin Protectant (Ointment)

Warnings

For external use only

Directions



Apply as needed.

Do Not Use On (Do not use on)



deep or puncture wounds

animal bites

serious burns

Active Ingredient (Active ingredient)

Petrolatun 41%

Inactive Ingredients (Inactive ingredients)



Mineral Oil

Ceresin

Lanolin

Bisabolol

Glycerin

Panthenol

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)



condition worsens

symptoms last more than 7days 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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)