SPL v1
SPL
SPL Set ID 3d379d5b-e939-9391-e063-6294a90a375c
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (33 g)
Inactive Ingredients
Peg-30 Dipolyhydroxystearate (4000 Mw) Lanolin Alcohols Water Propylparaben Sodium Chloride Dmdm Hydantoin Paraffin Mineral Oil Propylene Glycol Methylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01
Description

Petrolatum 33%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Petrolatum 33%

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
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

Petrolatum 33%

Inactive Ingredients

Inactive Ingredients: Water, Propylene Glycol, Mineral Oil, PEG-30 Dipolyhydroxystearate, Lanolin Alcohols, Paraffin, DMDM Hydantoin, Methylparaben, Sodium Chloride, Propylparaben

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, 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
Section 51945-4 (51945-4)

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

Petrolatum 33%

Inactive Ingredients

Inactive Ingredients: Water, Propylene Glycol, Mineral Oil, PEG-30 Dipolyhydroxystearate, Lanolin Alcohols, Paraffin, DMDM Hydantoin, Methylparaben, Sodium Chloride, Propylparaben

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: 2026-02-15T12:07:24.157490 · Updated: 2026-03-14T23:10:48.259693