Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID de44ac01-ba17-4f97-ac12-9ea348013bde
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (495 mg)
Inactive Ingredients
Mineral Oil Microcrystalline Wax Glycerin Paraffin Ceramide Np Ceramide Ap Carbomer Water Triethyl Citrate Sodium Lauroyl Lactylate Sodium Hyaluronate Cholesterol .alpha.-tocopherol Acetate Tocopherol Caprylyl Glycol Panthenol Phytosphingosine Xanthan Gum Benzoic Acid Synthetic Wax (1200 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Petrolatum 49.5%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Petrolatum 49.5%

Uses

temporarily protects minor:

    • cuts • scrapes • burns

• temporarily protects and helps relieve chafed, chapped or cracked skin and lips

• helps protect from the drying effects of wind and cold weather

Section 51945-4

Warnings

For external use only

Directions

apply as needed

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

Petrolatum 49.5%

Inactive Ingredients

mineral oil, microcrystalline wax, glycerin, paraffin, synthetic wax,

ceramide NP, ceramide AP, ceramide EOP, carbomer, water, triethyl

citrate, sodium lauroyl lactylate, sodium hyaluronate, cholesterol,

tocopheryl acetate, tocopherol, caprylyl glycol, panthenol,

phytosphingosine, xanthan gum, benzoic acid

Questions Or Comments?

Toll-free number 1-888-768-2915

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.


Structured Label Content

Uses

temporarily protects minor:

    • cuts • scrapes • burns

• temporarily protects and helps relieve chafed, chapped or cracked skin and lips

• helps protect from the drying effects of wind and cold weather

Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions

apply as needed

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)

Petrolatum 49.5%

Inactive Ingredients (Inactive ingredients)

mineral oil, microcrystalline wax, glycerin, paraffin, synthetic wax,

ceramide NP, ceramide AP, ceramide EOP, carbomer, water, triethyl

citrate, sodium lauroyl lactylate, sodium hyaluronate, cholesterol,

tocopheryl acetate, tocopherol, caprylyl glycol, panthenol,

phytosphingosine, xanthan gum, benzoic acid

Questions Or Comments? (Questions or comments?)

Toll-free number 1-888-768-2915

When Using This Product (When using this product)

do not get into 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.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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