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

Purpose

External Analgesic Skin Protectant

Description

Menthol 0.44% Zinc Oxide 20.625%


Medication Information

Warnings

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes
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

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

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

Description

Menthol 0.44% Zinc Oxide 20.625%

Package Label



Menthol and Zinc Oxide Ointment

Active Ingredients

Menthol 0.44%

Zinc Oxide 20.625%

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

Warnings

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes
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

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

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

Package Label (Package label)



Menthol and Zinc Oxide Ointment

Active Ingredients

Menthol 0.44%

Zinc Oxide 20.625%

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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