Zinc Oxide And Menthol Ointment
FDA Label NDC 87455-0001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Formulations India Private Limited for the product Zinc Oxide And Menthol (NDC 87455-0001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, stop use and ask doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

Active Ingredients                                        Purpose
Menthol 0.44%...........................External analgesic/anti-itch
Zinc Oxide 20.6%......Skin protectant/anorectal astringent 

Uses

  • A moisture barrier that prevents and heals skin irritations from
  • urine
  • diarrhea
  • prespiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings

For external use only

When Using This Product

  • not for deep or punctured wounds
  • avoid contact with eyes

Stop Use And Ask Doctor If

  • In case of accidental ingestion contact a physician or Poison Control Center right away
  • if condition worsens or does not improve within 7 days, consult a doctor

Keep Out Of Reach Of Children.

Directions

Cleanse skin gently with mid skin cleanser. Pat dry or allow to air dry. apply a thin layer of Hydroseptine 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.

Inactive Ingredients:

Other informationstore at room temperature 15-30 C (59-86 F)

Inactive ingredientscalamine, chlorothymol, glycerin, lanoline,phenol, sodium bicarbonate, and thymol,white petrolatum

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Manufactured By:

Akron Formulations India Private Limited

134B, Block-B, Bollaram, Jinnaram Mandal, Medak,

Hyderabad, Telangana 502325, India (IND)

This product is not manufactured or distributed by Calmoseptine Inc., owner of the registered trademark Calmoseptine.

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