SPL v1
SPL
SPL Set ID 3d366857-5178-9032-e063-6294a90a40f3
Route
TOPICAL
Published
Effective Date 2025-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
White Petrolatum (66.335 g) Zinc Oxide (20.625 g) Menthol (0.44 g)
Inactive Ingredients
Phenol Thymol Mineral Oil Sodium Bicarbonate Ferric Oxide Red Glycerin Lanolin

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Menthol 0.44% White Petrolatum 66.335% Zinc Oxide 20.625%

Purpose

Menthol 0.44%.........................................Analgesic White Petrolatum 66.335%...............................Protectant Zinc Oxide 20.625%............Astringent / Protectant


Medication Information

Purpose

Menthol 0.44%.........................................Analgesic

White Petrolatum 66.335%...............................Protectant

Zinc Oxide 20.625%............Astringent / Protectant

Description

Menthol 0.44% White Petrolatum 66.335% Zinc Oxide 20.625%

Uses
  • gives temporary relief of local itching and discomfort in the perianal area
  • temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • temporarily protects irritated areas
  • temporarily relieves burning
  • provides temporary relief from skin irritations
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • temporarily protects inflamed perianal skin
  • temporarily relieves the symptoms of perianal skin irritation
  • may provide a cooling sensation
Section 51945-4

Warnings

Warnings

For external use only

Allergy Alert: certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Directions

Directions

  • Adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to affected area up to 6 times daily.
  • Children under 12 years of age: consult a doctor
Active Ingredients

Menthol 0.44%

White Petrolatum 66.335%

Zinc Oxide 20.625%

Inactive Ingredients

Inactive Ingredients: Calamine, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol

When Using This Product

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask Doctor If

Stop using and ask a doctor if

  • condition worsens or does not improve in 7 days
  • bleeding occurs, consult a doctor promptly
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
  • gives temporary relief of local itching and discomfort in the perianal area
  • temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • temporarily protects irritated areas
  • temporarily relieves burning
  • provides temporary relief from skin irritations
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • temporarily protects inflamed perianal skin
  • temporarily relieves the symptoms of perianal skin irritation
  • may provide a cooling sensation
Section 51945-4 (51945-4)

Purpose

Menthol 0.44%.........................................Analgesic

White Petrolatum 66.335%...............................Protectant

Zinc Oxide 20.625%............Astringent / Protectant

Warnings

Warnings

For external use only

Allergy Alert: certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Directions

Directions

  • Adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to affected area up to 6 times daily.
  • Children under 12 years of age: consult a doctor
Active Ingredients

Menthol 0.44%

White Petrolatum 66.335%

Zinc Oxide 20.625%

Inactive Ingredients

Inactive Ingredients: Calamine, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol

When Using This Product (When using this product)

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask Doctor If (Stop use and ask doctor if)

Stop using and ask a doctor if

  • condition worsens or does not improve in 7 days
  • bleeding occurs, consult a doctor promptly
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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