SPL v1
SPL
SPL Set ID f0555263-135c-47ec-8103-9acb4a7da4c8
Route
TOPICAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (100 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-12
Description

Petrolatum 100%                                 Skin Protectant

Purpose

Petrolatum 100%                                 Skin Protectant

Medication Information

Purpose

Petrolatum 100%                                 Skin Protectant

Description

Petrolatum 100%                                 Skin Protectant

Uses
  • Temporarily protects minor cuts, scrapes, and burns.
  • Temporarily protects and helps relieve chapped or cracked skin and lips.
  • Helps protect from the drying effects of wind and cold weather.
Section 50565-1

Warnings
  • For external use only. 
  • Do not apply over deep puncture wounds, infections, or lacerations.
  • If redness or swelling develops, consult a physician promptly.
  • Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions

Apply as needed.

Product Label

Inactive Ingredients

None

Active Ingredient                                Purpose

Petrolatum 100%                                 Skin Protectant

Structured Label Content

Uses
  • Temporarily protects minor cuts, scrapes, and burns.
  • Temporarily protects and helps relieve chapped or cracked skin and lips.
  • Helps protect from the drying effects of wind and cold weather.
Section 50565-1 (50565-1)

Warnings
  • For external use only. 
  • Do not apply over deep puncture wounds, infections, or lacerations.
  • If redness or swelling develops, consult a physician promptly.
  • Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions

Apply as needed.

Product Label (Product label)

Inactive Ingredients (Inactive ingredients)

None

Active Ingredient                                Purpose

Petrolatum 100%                                 Skin Protectant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:39.754665 · Updated: 2026-03-14T23:11:22.461750