SPL v4
SPL
SPL Set ID e35d913e-2195-4e3d-ae38-f010317140fd
Route
TOPICAL
Published
Effective Date 2016-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (0.1 g)
Inactive Ingredients
Shea Butter

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-14
Description

White Petrolatum USP (99.6%)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum USP (99.6%)

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

Label

Warnings

For external use only

Directions

apply as needed

Do Not Use On

deep or puncture wounds, animal bites, serious burns

Active Ingredient

White Petrolatum USP (99.6%)

Inactive Ingredients

butyrospermum parkii (shea butter), fragrance

Questions Or Comments?

1-800-925-4733

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If

condition worsens, symptoms last longer than 7 days 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

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

Label

Purpose

Skin Protectant

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

White Petrolatum USP (99.6%)

Inactive Ingredients (Inactive ingredients)

butyrospermum parkii (shea butter), fragrance

Questions Or Comments? (Questions or comments?)

1-800-925-4733

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 longer 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:52.721472 · Updated: 2026-03-14T23:05:59.331876