Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 867a9e5e-5d8a-4bfa-8f17-faf6098edc23

Route

TOPICAL

Published

Effective Date 2012-01-26

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

Description

PETROLATUM 41%

Purpose

SKIN PROTECTANT

Medication Information

Purpose

SKIN PROTECTANT

Description

PETROLATUM 41%

Uses

TEMPORARILY PROTECTS MINOR: CUTS, SCRAPES, BURNS.

TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFED OR CRACKED SKIN AND LIPS.

HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER.

Warnings

FOR EXTERNAL USE ONLY.

Directions

APPLY AS NEEDED.

Label Copy

Active Ingredient

PETROLATUM 41%

Inactive Ingredients:

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

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE 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 Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS.

Structured Label Content

Uses (USES)

TEMPORARILY PROTECTS MINOR: CUTS, SCRAPES, BURNS.

TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFED OR CRACKED SKIN AND LIPS.

HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER.

Purpose (PURPOSE)

SKIN PROTECTANT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

APPLY AS NEEDED.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

PETROLATUM 41%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE 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 Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS.

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, CHAFED 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.", "ACTIVE INGREDIENT": "PETROLATUM 41%", "INACTIVE INGREDIENTS:": "MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL.", "WHEN USING THIS PRODUCT": "AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE 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 DOCTOR IF": "IRRITATION OR REDNESS DEVELOPS AND LASTS."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:24.447435 · Updated: 2026-03-14T22:52:58.895821