1120a592-f206-41c1-a91b-1d1c7f257cf9

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
Purpose

Petrolatum 30%                                 Skin Protectant

Description

Petrolatum 30%                                 Skin Protectant

Medication Information

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.
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.
Purpose

Petrolatum 30%                                 Skin Protectant

Directions

Apply as needed.

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).

Description

Petrolatum 30%                                 Skin Protectant

Section 50565-1

Product Label

Active Ingredient                                Purpose

Petrolatum 30%                                 Skin Protectant

Structured Label Content

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.
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.
Directions

Apply as needed.

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).

Section 50565-1 (50565-1)

Product Label (Product label)

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