3ab7bfb2-bbcf-0822-e063-6294a90af084

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
Purpose

Purpose : Skin Protectant

Description

Active Ingredient: Petrolatum 44.28%

Medication Information

Warnings

Warnings

For external use only

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
Purpose

Purpose: Skin Protectant

Directions

Directions: Apply as needed

Inactive Ingredients

Inactive Ingredients

Mineral Oil, Microcrystalline Wax, Paraffin, Lanolin

Description

Active Ingredient: Petrolatum 44.28%

Section 51945-4

Do Not Use On

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

Active Ingredient

Active Ingredient: Petrolatum 44.28%

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, burns
  • Temporarily protects and helps relieve chafed, chapped or cracked skin and lips
  • Helps 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, Microcrystalline Wax, Paraffin, Lanolin

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 44.28%

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