drug facts

drug facts
SPL v1
SPL
SPL Set ID 9744cc42-2331-42db-a4ee-0b304bd96547
Route
topical
Published
Effective Date 2012-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (41 g)
Inactive Ingredients
mineral oil ceresin lanolin alcohols panthenol glycerin levomenol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-06-22
Purpose

SKIN PROTECTANT

Description

PETROLATUM 41%

Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED, CHAFED OR CRACKED SKIN AND LIPS. HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER.

Purpose

SKIN PROTECTANT

Directions

APPLY AS REQUIRED.

Other Information

DO NOT USE IF INNER SEAL IS MISSING OR BROKEN. STORE AT ROOM TEMPERATURE.

Inactive Ingredients

MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL.

Description

PETROLATUM 41%

Do Not Use

ON DEEP OR PUNCTURE WOUNDS, ON INFECTED AREAS OR ON SERIOUS BURNS.

Label Copy

Active Ingredient

PETROLATUM 41%

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Stop Use and Ask Doctor If

CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Uses (USES)

TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED, CHAFED OR CRACKED SKIN AND LIPS. HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER.

Purpose (PURPOSE)

SKIN PROTECTANT

Directions (DIRECTIONS)

APPLY AS REQUIRED.

Other Information (OTHER INFORMATION)

DO NOT USE IF INNER SEAL IS MISSING OR BROKEN. STORE AT ROOM TEMPERATURE.

Inactive Ingredients (INACTIVE INGREDIENTS)

MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL.

Do Not Use (DO NOT USE)

ON DEEP OR PUNCTURE WOUNDS, ON INFECTED AREAS OR ON SERIOUS BURNS.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

PETROLATUM 41%

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.204796 · Updated: 2026-03-14T22:53:10.919261