drug facts

drug facts

SPL v1

SPL

SPL Set ID cbe10b90-354e-4396-b878-cff31a4b0e2e

Route

topical

Published

Effective Date 2012-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

petrolatum (410 mg)

Inactive Ingredients

mineral oil ceresin lanolin alcohols panthenol glycerin levomenol

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2012-10-15

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 OR CRACKED SKIN AND LIPS. HELPS PROTECT FOM THE DRYING EFFECTS OF COLD WIND AND WEATHER.

Purpose

SKIN PROTECTANT

Directions

APPLY AS NEEDED.

Other Information

STORE AT ROOM TEMPERATURE.

Inactive Ingredients

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

Description

PETROLATUM 41%

Section 51945-4

Active Ingredient

PETROLATUM 41%

When Using This Product

DO NOT GET INTO EYES. IF CONTACT OCCURS, WINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children

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

Stop Using This Product and Ask A Doctor If

CONDITION WORSENS OR SYMPTOMS PERSIST MORE THAN SEVEN DAYS OR CLEAR UP AND RECUR WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES OR ON SERIOUS BURNS.

Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Uses (USES)

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

Purpose (PURPOSE)

SKIN PROTECTANT

Directions (DIRECTIONS)

APPLY AS NEEDED.

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE.

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

PETROLATUM 41%

When Using This Product (WHEN USING THIS PRODUCT)

DO NOT GET INTO EYES. IF CONTACT OCCURS, WINSE THOROUGHLY WITH WATER.

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.

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

CONDITION WORSENS OR SYMPTOMS PERSIST MORE THAN SEVEN DAYS OR CLEAR UP AND RECUR WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES OR ON SERIOUS BURNS.

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIM", "strengthNumerator": "410", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN ALCOHOLS", "unii": "884C3FA9HE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEVOMENOL", "unii": "24WE03BX2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND LIPS. HELPS PROTECT FOM THE DRYING EFFECTS OF COLD WIND AND WEATHER.", "PURPOSE": "SKIN PROTECTANT", "WARNINGS": "FOR EXTERNAL USE ONLY", "DIRECTIONS": "APPLY AS NEEDED.", "ACTIVE INGREDIENT": "PETROLATUM 41%", "OTHER INFORMATION": "STORE AT ROOM TEMPERATURE.", "INACTIVE INGREDIENTS": "MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL.", "WHEN USING THIS PRODUCT": "DO NOT GET INTO EYES. IF CONTACT OCCURS, WINSE THOROUGHLY WITH WATER.", "KEEP OUT OF REACH OF CHILDREN": "IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.", "STOP USING THIS PRODUCT AND ASK A DOCTOR IF": "CONDITION WORSENS OR SYMPTOMS PERSIST MORE THAN SEVEN DAYS OR CLEAR UP AND RECUR WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES OR ON SERIOUS BURNS."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:31.998530 · Updated: 2026-03-14T22:53:17.603568