drug facts

drug facts

SPL v1

SPL

SPL Set ID 16734504-fa93-4fff-bbcd-ad2b6342f55f

Route

topical

Published

Effective Date 2012-02-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

petrolatum (41.0 g)

Inactive Ingredients

mineral oil ceresin lanolin alcohols panthenol glycerin .alpha.-bisabolol, (+/-)-

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2012-01-03

Purpose

SKIN PROTECTANT

Description

PETROLATUM 41%

Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

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

Purpose

SKIN PROTECTANT

Directions

APPLY AS NEEDED.

Other Information

STORE AT ROOM TEMPERATURE.

Description

PETROLATUM 41%

Do Not Use

ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS.

Label Copy

Active Ingredient

PETROLATUM 41%

Inactive Ingredients:

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

Questions Or Comments?

1-800-910-6874

When Using This Product

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

Keep Out of Reach of Children

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

Stop Using This Product and Ask A Doctor If

CONDITION WORSENS OR SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.

Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Uses (USES)

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

Purpose (PURPOSE)

SKIN PROTECTANT

Directions (DIRECTIONS)

APPLY AS NEEDED.

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE.

Do Not Use (DO NOT USE)

ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

PETROLATUM 41%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-910-6874

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE 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 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 LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "41.0", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "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": ".ALPHA.-BISABOLOL, (+/-)-", "unii": "36HQN158VC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND RELIEVES CHAPPED OR CRACKED SKIN AND LIPS. HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER.", "PURPOSE": "SKIN PROTECTANT", "WARNINGS": "FOR EXTERNAL USE ONLY.", "DIRECTIONS": "APPLY AS NEEDED.", "DO NOT USE": "ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS.", "ACTIVE INGREDIENT": "PETROLATUM 41%", "OTHER INFORMATION": "STORE AT ROOM TEMPERATURE.", "INACTIVE INGREDIENTS:": "MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL.", "QUESTIONS OR COMMENTS?": "1-800-910-6874", "WHEN USING THIS PRODUCT": "AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.", "KEEP OUT OF REACH OF CHILDREN": "IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY.", "STOP USING THIS PRODUCT AND ASK A DOCTOR IF": "CONDITION WORSENS OR SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:25.082924 · Updated: 2026-03-14T22:53:00.263233