SPL v3
SPL
SPL Set ID 3a1721f6-1bb0-cd47-e063-6394a90a148e
Route
TOPICAL
Published
Effective Date 2025-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (49.9 g)
Inactive Ingredients
Lanolin Aluminum Stearate Corn Oil Phenoxyethanol Aloe Vera Leaf Zinc Oxide .alpha.-tocopherol Acetate Sorbitan Sesquioleate Paraffin Ethylhexylglycerin Chloroxylenol Water Propylene Glycol Cholecalciferol Vitamin A Palmitate Imidurea Yellow Wax Mineral Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-17

Description

Petrolatum 49.9%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Petrolatum 49.9%

Uses
  • Helps treat and prevent incontinence or diaper rash
  • Protects chafed skin associated with incontinence or diaper rash and helps seal out wetness
  • Temporarily protects and helps relieve chafed, chapped or cracked skin
Section 51945-4

Warnings

Warnings

For External Use Only

Directions

For skin protectant use: apply as needed

For incontinence or diaper rash:

  • Change wet and soiled undergarments promptly
  • Gently cleanse affected skin, and allow to dry
  • Apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use On

Do not use on deep or puncture wounds, animal bites, or serious burns

Active Ingredient

Petrolatum 49.9%

Inactive Ingredients

Mineral Oil, Water, Propylene Glycol, Paraffin, Zinc Oxide, Sorbitan Sesquioleate, Lanolin, Beeswax, Aluminum Stearate, Corn Oil, Phenoxyethanol, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Chloroxylenol, Aloe Barbadensis Leaf Extract, Cholecalciferol, Vitamin A Palmitate, Vitamin E Acetate

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

Uses
  • Helps treat and prevent incontinence or diaper rash
  • Protects chafed skin associated with incontinence or diaper rash and helps seal out wetness
  • Temporarily protects and helps relieve chafed, chapped or cracked skin
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

Warnings

For External Use Only

Directions

For skin protectant use: apply as needed

For incontinence or diaper rash:

  • Change wet and soiled undergarments promptly
  • Gently cleanse affected skin, and allow to dry
  • Apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use On (Do not use on)

Do not use on deep or puncture wounds, animal bites, or serious burns

Active Ingredient

Petrolatum 49.9%

Inactive Ingredients

Mineral Oil, Water, Propylene Glycol, Paraffin, Zinc Oxide, Sorbitan Sesquioleate, Lanolin, Beeswax, Aluminum Stearate, Corn Oil, Phenoxyethanol, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Chloroxylenol, Aloe Barbadensis Leaf Extract, Cholecalciferol, Vitamin A Palmitate, Vitamin E Acetate

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

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