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SPL v1

SPL

SPL Set ID 45878c3c-d05d-984c-e063-6294a90a4661

Route

topical

Published

Effective Date 2025-12-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

petrolatum (41 g)

Inactive Ingredients

mineral oil lanolin alcohols dexpanthenol glycerin ceresin

Identifiers & Packaging

Pill Appearance

Shape: freeform

Marketing Status

otc monograph drug active Since 2025-12-16

Purpose

Skin Protectant

Description

Petrolatum 41%

Medication Information

Warnings

For external use only

Do not get into eyes

Uses

• Temporarily protects minor • cuts • scrapes • burns

• Temporarily protects and helps relieve chapped or cracked skin and lips

• Helps protect skin from the drying effects of wind and cold weather

Purpose

Skin Protectant

Directions

Apply as needed

Other Information

• Store at room temperature 15º - 30ºC (59º - 86ºF)

Inactive Ingredients

ceresin wax, dexpanthenol, glycerin, lanoline alcohol, mineral oil

Description

Petrolatum 41%

Questions?

1-888-DYNAREX Monday - Friday 9AM - 5PM EST

Label

1465 Label

Do Not Use

• On deep or puncture wounds • Animal bites • Serious burns

Active Ingredient

Petrolatum 41%

Stop Use and Ask A Doctor If

• Condition worsens

• Symptoms last more than 7 days or clear up and occur again with a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Warnings

For external use only

Do not get into eyes

Uses

• Temporarily protects minor • cuts • scrapes • burns

• Temporarily protects and helps relieve chapped or cracked skin and lips

• Helps protect skin from the drying effects of wind and cold weather

Purpose

Skin Protectant

Directions

Apply as needed

Other Information (Other information)

• Store at room temperature 15º - 30ºC (59º - 86ºF)

Inactive Ingredients (Inactive ingredients)

ceresin wax, dexpanthenol, glycerin, lanoline alcohol, mineral oil

Questions?

1-888-DYNAREX Monday - Friday 9AM - 5PM EST

Label

1465 Label

Do Not Use (Do not use)

• On deep or puncture wounds • Animal bites • Serious burns

Active Ingredient (Active ingredient)

Petrolatum 41%

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

• Condition worsens

• Symptoms last more than 7 days or clear up and occur again with a few days

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN ALCOHOLS", "unii": "884C3FA9HE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXPANTHENOL", "unii": "1O6C93RI7Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "41", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "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 skin from the drying effects of wind and cold weather", "Label": "1465 Label", "Purpose": "Skin Protectant", "Warnings": "For external use only Do not get into eyes", "Directions": "Apply as needed", "Do not use": "• On deep or puncture wounds • Animal bites • Serious burns", "Questions?": "1-888-DYNAREX Monday - Friday 9AM - 5PM EST", "Active ingredient": "Petrolatum 41%", "Other information": "• Store at room temperature 15º - 30ºC (59º - 86ºF)", "Inactive ingredients": "ceresin wax, dexpanthenol, glycerin, lanoline alcohol, mineral oil", "Stop use and ask a doctor if": "• Condition worsens • Symptoms last more than 7 days or clear up and occur again with a few days", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:41.646344 · Updated: 2026-03-14T23:11:26.161918