1463 Aquasoothe

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

Description

Petrolatum 41%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Petrolatum 41%

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

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.

Structured Label Content

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 (Do not use)

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

Questions?

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

Active Ingredient (Active ingredient)

Petrolatum 41%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

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