Menthol And Zinc Oxide Ointment – Anorectal Ointment

Menthol And Zinc Oxide Ointment – Anorectal Ointment
SPL v5
SPL
SPL Set ID c24e2dab-cab4-38f4-e053-2995a90aabae
Route
TOPICAL
Published
Effective Date 2021-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Menthol 0.44% Zinc Oxide 20.625%

Purpose

External Analgesic Skin Protectant


Medication Information

Purpose

External Analgesic

Skin Protectant

Description

Menthol 0.44% Zinc Oxide 20.625%

Uses

A moisture barrier that prevents & helps heal skin irritations from:

  • Urine
  • Diarrhea
  • Perspiration
  • Fistula drainage
  • Feeding tube site leakage
  • Wound drainage (peri-wound skin)
  • Minor burns
  • Cuts
  • Scrapes
  • Itching
Warnings

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes
Directions
  • Cleans with mild skin cleanser
  • Pat dry or allow to air dry
  • Apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.
Package Label



Menthol and Zinc Oxide Ointment

Other Information
  • Store at room temperature 20°- 25° C (68°F-77°F)
Active Ingredients

Menthol 0.44%

Zinc Oxide 20.625%

Inactive Ingredients

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin, Isopropyl Alcohol, Hard Paraffin

Stop Use and Ask 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

A moisture barrier that prevents & helps heal skin irritations from:

  • Urine
  • Diarrhea
  • Perspiration
  • Fistula drainage
  • Feeding tube site leakage
  • Wound drainage (peri-wound skin)
  • Minor burns
  • Cuts
  • Scrapes
  • Itching
Purpose

External Analgesic

Skin Protectant

Warnings

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes
Directions
  • Cleans with mild skin cleanser
  • Pat dry or allow to air dry
  • Apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.
Package Label (Package label)



Menthol and Zinc Oxide Ointment

Other Information
  • Store at room temperature 20°- 25° C (68°F-77°F)
Active Ingredients

Menthol 0.44%

Zinc Oxide 20.625%

Inactive Ingredients

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin, Isopropyl Alcohol, Hard Paraffin

Stop Use and Ask Doctor If (Stop use and ask 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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