SPL v1
SPL
SPL Set ID 1120a592-f206-41c1-a91b-1d1c7f257cf9
Route
TOPICAL
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (30 g)
Inactive Ingredients
Mineral Oil Methylparaben Water .alpha.-tocopherol Stearic Acid Glyceryl Monostearate Propylparaben Sodium Lauryl Sulfate Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetostearyl Alcohol Ceteth-20 Trolamine Cocoa Butter Fd&c Red No. 40 Fd&c Yellow No. 5

Identifiers & Packaging

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

Petrolatum 30%                                 Skin Protectant

Purpose

Petrolatum 30%                                 Skin Protectant

Medication Information

Purpose

Petrolatum 30%                                 Skin Protectant

Description

Petrolatum 30%                                 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 use on deep wounds.
  • When using this product do not get into eyes.
  • 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. If swallowed, get medical help or contact a Poison Control Center right away.
Directions

Apply as needed.

Product Label

Inactive Ingredients

Water (Aqua), Mineral Oil, Stearic Acid, Glyceryl Monostearate, Cetearyl Alcohol, CM 1000, Fragrance, Triethanolamine, Carbopol 940, Methyl Paraben, Propyl Paraben, Sodium Lauryl Sulphate, Vitamin E, Cocoa Butter, FD&C Red 40 (CI No. 16035), FD&C Yellow 5 (CI No. 19140).

Active Ingredient                                Purpose

Petrolatum 30%                                 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 use on deep wounds.
  • When using this product do not get into eyes.
  • 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. 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)

Water (Aqua), Mineral Oil, Stearic Acid, Glyceryl Monostearate, Cetearyl Alcohol, CM 1000, Fragrance, Triethanolamine, Carbopol 940, Methyl Paraben, Propyl Paraben, Sodium Lauryl Sulphate, Vitamin E, Cocoa Butter, FD&C Red 40 (CI No. 16035), FD&C Yellow 5 (CI No. 19140).

Active Ingredient                                Purpose

Petrolatum 30%                                 Skin Protectant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:38.700803 · Updated: 2026-03-14T23:11:19.831195