SPL v3
SPL
SPL Set ID 488bd9ab-5f52-4ff2-9474-07abf8ba4a08
Route
TOPICAL
Published
Effective Date 2016-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (100 g)

Identifiers & Packaging

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

White Petrolatum USP (100%)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

White Petrolatum USP (100%)

Use

helps protect chapped skin

Label

Warnings

For external use only

Directions

apply as needed

Do Not Use On

deep or puncture wounds, animal bites, serious burns

See A Doctor If

condition lasts more than 7 days

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

Use

helps protect chapped skin

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

See A Doctor If (See a doctor if)

condition lasts more than 7 days

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.639827 · Updated: 2026-03-14T22:54:23.335310