3d379d5b-e939-9391-e063-6294a90a375c

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
Purpose

Skin Protectant

Description

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

Skin Protectant

Directions

Directions apply as needed

Inactive Ingredients

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

Description

Petrolatum 33%

Section 51945-4

Do Not Use On

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns
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

Skin Protectant

Directions

Directions apply as needed

Inactive Ingredients

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

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

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

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