SPL v1
SPL
SPL Set ID 76257333-d46b-4e3e-a87b-0e3d7c8d390f
Route
TOPICAL
Published
Effective Date 2013-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-01
Description

Active Ingredient White Petrolatum USP (100%)

Medication Information

Warnings and Precautions
W arnings: For External Use Only 
Indications and Usage

Uses : Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chapped or sracked skin and lips ●Helps protect from the drying effects of wind and cold weather.

Dosage and Administration

Directions Apply as needed

Description

Active Ingredient White Petrolatum USP (100%)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product ●do not get into eyes

Section 50569-3

See a doctor if ●condition lasts for more than 72 hours

Section 50570-1

Do not use on ● over deep or puncture wounds ●animal bites ●serious burns

Section 51945-4

Section 55105-1
Pur pose

 Skin protectant
Section 55106-9
Active Ingredient

White Petrolatum USP (100%)

Structured Label Content

Indications and Usage (34067-9)

Uses : Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chapped or sracked skin and lips ●Helps protect from the drying effects of wind and cold weather.

Dosage and Administration (34068-7)

Directions Apply as needed

Warnings and Precautions (34071-1)
W arnings: For External Use Only 
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product ●do not get into eyes

Section 50569-3 (50569-3)

See a doctor if ●condition lasts for more than 72 hours

Section 50570-1 (50570-1)

Do not use on ● over deep or puncture wounds ●animal bites ●serious burns

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
Pur pose

 Skin protectant
Section 55106-9 (55106-9)
Active Ingredient

White Petrolatum USP (100%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:35.983740 · Updated: 2026-03-14T22:53:25.926266