drug facts

drug facts

SPL v1

SPL

SPL Set ID db5480ca-d965-43dc-bca1-9ee943155efd

Route

topical

Published

Effective Date 2017-07-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

petrolatum (0.41 mg)

Inactive Ingredients

mineral oil ceresin lanolin alcohols panthenol glycerin levomenol

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2017-07-13

Purpose

Skin protectant

Description

Petrolatum 41%

Medication Information

Warnings

For external use only.

Uses

temporarily protects minor cuts, scrapes and 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

Directions

Apply as needed

Other Information

Store at room temperature.

Inactive Ingredients

Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol.

Description

Petrolatum 41%

Label Copy

Do Not Use On

deep or puncture wounds, infections or lacerations.

Active Ingredient

Petrolatum 41%

Questions Ro Comments?

1-877-307-2192

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If

condition worsens or does not improve within 7 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

For external use only.

Uses

temporarily protects minor cuts, scrapes and 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

Directions

Apply as needed

Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol.

Label Copy

Do Not Use On (Do not use on)

deep or puncture wounds, infections or lacerations.

Active Ingredient (Active ingredient)

Petrolatum 41%

Questions Ro Comments? (Questions ro comments?)

1-877-307-2192

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or does not improve within 7 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

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "0.41", "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 and 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", "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 ro comments?": "1-877-307-2192", "When using this product": "avoid contact with eyes. If contact occurs, rinse thoroughly with water.", "Stop use and ask a doctor if": "condition worsens or does not improve within 7 days.", "Keep out of reach of children.": "In case of accidental ingestion, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:23.538883 · Updated: 2026-03-14T22:54:48.761962