Calmafx
FDA Label NDC 75904-3246

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Choice Medical Supply for the product Calmafx (NDC 75904-3246). 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, otc - ask doctor, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 0.45%

Calamine 2%

Zinc Oxide 18%

Purpose

External Analgesic, Skin Protectant

Uses

A moisture barrier that prevents and helps protect skin irritations from

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings

  • For external use only.
  • When using this product
  • do not get into eyes.

Otc - Ask Doctor

Stop use and ask doctor if :

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Otc - 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.

Directions

When practical, gently cleanse and dry area.

  • Adults: Apply externally to affected area up to 6 times daily or after each incontinent episode or diaper change.
  • Children under 12 years: Consult a doctor.

Other Information

Store at 15-30°C (59-86°F)

Inactive Ingredients:

Beeswax, Disodium EDTA, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sodium Borate, Sorbitan Sesquioleate

Questions Or Comments?

First Choice Medical Supply

127 Interstate Dr.

Richland, MS 39218

800-809-4556 or visit www.fcms.com

Item # 33433

Images Of Representative Artwork

CalmafxSachet.jpg

Sachet (Calmafxsachet)

Sachet (Calmafxsachet)

 calmafxtube.jpg
Tube (Calmafxtube)

Tube (Calmafxtube)

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