SPL v1
SPL
SPL Set ID b77c8b7e-9f3e-4050-a30c-aa6e1e6a2280
Route
TOPICAL
Published
Effective Date 2010-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (99.9 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-10-21
Description

Active Ingredient White Petroleum (99.9%)

Medication Information

Warnings and Precautions

WARNING: FOR EXTERNAL USE ONLY

Indications and Usage

Uses : Temporarily protects & helps relieve minor cuts, scrapes, burns & chapped or cracked skin & lips.

Helps protect from the drying effects of wind & cold weather.

Dosage and Administration

DIRECTIONS: Apply to clean & dry area as necessary.

Description

Active Ingredient White Petroleum (99.9%)

Section 50565-1

KEEP OUT OF REACH OF CHILDREN If swallowed get medical help or contact Poison Control right away. If redness or swelling develops, consult a physician

Section 50566-9

STOP USE AND ASK DOCTOR If condition does not improve or lasts more than 7 days.

Section 50570-1

DO NOT USE ON: Deep Wounds/Puncture Wounds Lacerations/Infections . Serious Burns . Animal Bites

Section 51727-6

Ingredient Perfume (0.1%)

Section 55105-1

Purpose Skin Protectant

Section 55106-9

Active Ingredient White Petroleum (99.9%)

Package Display

Structured Label Content

Indications and Usage (34067-9)

Uses : Temporarily protects & helps relieve minor cuts, scrapes, burns & chapped or cracked skin & lips.

Helps protect from the drying effects of wind & cold weather.

Dosage and Administration (34068-7)

DIRECTIONS: Apply to clean & dry area as necessary.

Warnings and Precautions (34071-1)

WARNING: FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN If swallowed get medical help or contact Poison Control right away. If redness or swelling develops, consult a physician

Section 50566-9 (50566-9)

STOP USE AND ASK DOCTOR If condition does not improve or lasts more than 7 days.

Section 50570-1 (50570-1)

DO NOT USE ON: Deep Wounds/Puncture Wounds Lacerations/Infections . Serious Burns . Animal Bites

Section 51727-6 (51727-6)

Ingredient Perfume (0.1%)

Section 55105-1 (55105-1)

Purpose Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient White Petroleum (99.9%)

Package Display (PACKAGE DISPLAY)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:09.348977 · Updated: 2026-03-14T22:52:30.292621