3ab7248d-b914-9fdd-e063-6294a90ac4c8

SPL v1

SPL

SPL Set ID 3ab7248d-b914-9fdd-e063-6294a90ac4c8

Route

topical

Published

Effective Date 2025-09-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

petrolatum (33 g)

Inactive Ingredients

phenoxyethanol sodium chloride paraffin water ethylhexylglycerin peg-30 dipolyhydroxystearate propylene glycol mineral oil lanolin

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug active Since 2025-09-15

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Petrolatum 33%

Medication Information

Warnings

Warnings

For external use only

Uses

Uses:

Temporarily protects minor: cuts, scrapes, and burns
Temporarily protects and helps relieve chafed, chapped or cracked skin
Helps prevent and protect from the drying effects of wind and cold weather

Purpose

Purpose: Skin Protectant

Directions

Directions

Apply as needed

Inactive Ingredients

Inactive Ingredients

Mineral Oil, Paraffin, Water, PEG-30 Dipolyhydroxystearate, Propylene Glycol, Lanolin Anhydrous, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin

Description

Active Ingredient: Petrolatum 33%

Section 51945-4

Do Not Use On

Do not use on deep or puncture wounds, animal bites, serious burns

Active Ingredient

Active Ingredient: Petrolatum 33%

When Using This Product

When using this product do not get into the eyes

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 within a few days

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Structured Label Content

Warnings

Warnings

For external use only

Uses

Uses:

Temporarily protects minor: cuts, scrapes, and burns
Temporarily protects and helps relieve chafed, chapped or cracked skin
Helps prevent and protect from the drying effects of wind and cold weather

Purpose

Purpose: Skin Protectant

Directions

Directions

Apply as needed

Inactive Ingredients

Inactive Ingredients

Mineral Oil, Paraffin, Water, PEG-30 Dipolyhydroxystearate, Propylene Glycol, Lanolin Anhydrous, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin

Section 51945-4 (51945-4)

Do Not Use On (Do not use on)

Do not use on deep or puncture wounds, animal bites, serious burns

Active Ingredient

Active Ingredient: Petrolatum 33%

When Using This Product (When using this product)

When using this product do not get into the eyes

Stop Use and Ask A Doctor If (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 within a few days

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

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Advanced Ingredient Data

[{"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "33", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-30 DIPOLYHYDROXYSTEARATE", "unii": "9713Q0S7FO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Uses: Temporarily protects minor: cuts, scrapes, and burns Temporarily protects and helps relieve chafed, chapped or cracked skin Helps prevent and 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", "Do not use on": "Do not use on deep or puncture wounds, animal bites, serious burns", "Active Ingredient": "Active Ingredient: Petrolatum 33%", "Inactive Ingredients": "Inactive Ingredients Mineral Oil, Paraffin, Water, PEG-30 Dipolyhydroxystearate, Propylene Glycol, Lanolin Anhydrous, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin", "When using this product": "When using this product do not get into the eyes", "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 within a few days", "Keep out of reach of children": "Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:00.155667 · Updated: 2026-03-14T23:10:09.220745