SPL v3
SPL
SPL Set ID 6442a79c-65c1-422e-b68c-53ce4edf86cc
Route
TOPICAL
Published
Effective Date 2018-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (100 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-10

Description

White Petrolatum USP (100%)

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

White Petrolatum USP (100%)

Uses

temporarily protects minor: cuts, scrapes, burns.  temporarily protects and helps relieve chapped or cracked skin and lips.  helps protect from the drying effects of wind and cold weather

Warnings

For external use only.

Back Label

Directions

Apply as needed

Front Label

See A Doctor

if condition lasts more than 7 days.

Do Not Use On

deep or puncture wounds, animal bites, serious burns.

Active Ingredient

White Petrolatum USP (100%)

When Using This Product

do not get into eyes.

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 and lips.  helps protect from the drying effects of wind and cold weather

Purpose

Skin Protectant

Warnings

For external use only.

Back Label

Directions

Apply as needed

Front Label

See A Doctor (See a doctor)

if condition lasts more than 7 days.

Do Not Use On (Do not use on)

deep or puncture wounds, animal bites, serious burns.

Active Ingredient

White Petrolatum USP (100%)

When Using This Product (When using this product)

do not get into eyes.

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)