Menthol And Zinc Oxide
FDA Label NDC 61767-234

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blossom Pharmaceuticals for the product Menthol And Zinc Oxide (NDC 61767-234). 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 otc - active ingredient, purpose:, warnings:, indications & usage, dosage & administration:, keep out of reach of children, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                         Purpose

Menthol 0.44% v/v                            External Analgesic

                                                          First Aid Antiseptic

                                                          Antipuritic

Zinc Oxide 20.625% v/v                       Skin Protectant

                                                           Moisture Barrier         

Purpose:

A moisture barrier that prevents and 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:

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • Not for deep or puncture wounds.
  • Avoid contact with eyes.
  • If condition worsens or does not improve within 7 days, consult a doctor

Dosage & Administration:

  • Clean skin with mild skin cleanser
  • Pat dry or allow to air dry
  • Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection

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.

Inactive Ingredients

Inactive Ingredients: Calamine, Glycerine, Phenol, Lanolin, Heavy Liquid Paraffin, Sodium Bicarbonate, Thymol, White Soft Paraffin

Principal Display Panel

Principal Display Panel - Ointment

Blossom1275.jpg

Cala Ointment (Blossom1275)

Cala Ointment (Blossom1275)

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