SPL v2
SPL
SPL Set ID 3ab7bfb2-bbcf-0822-e063-6294a90af084
Route
TOPICAL
Published
Effective Date 2025-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (44.28 g)
Inactive Ingredients
Microcrystalline Wax Paraffin Mineral Oil Lanolin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-15
Description

Active Ingredient: Petrolatum 44.28%

Purpose

Purpose : Skin Protectant

Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Petrolatum 44.28%

Uses

Uses

  • Temporarily protects minor: cuts, scrapes, burns
  • Temporarily protects and helps relieve chafed, chapped or cracked skin and lips
  • Helps protect from the drying effects of wind and cold weather
Section 51945-4

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 44.28%

Inactive Ingredients

Inactive Ingredients

Mineral Oil, Microcrystalline Wax, Paraffin, Lanolin

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

Uses

Uses

  • Temporarily protects minor: cuts, scrapes, burns
  • Temporarily protects and helps relieve chafed, chapped or cracked skin and lips
  • Helps protect from the drying effects of wind and cold weather
Section 51945-4 (51945-4)

Purpose

Purpose: Skin Protectant

Warnings

Warnings

For external use only

Directions

Directions: Apply as needed

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 44.28%

Inactive Ingredients

Inactive Ingredients

Mineral Oil, Microcrystalline Wax, Paraffin, Lanolin

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:00.156612 · Updated: 2026-03-14T23:13:05.198485