FDA Label for Calmafx Moisture Barrier

View Indications, Usage & Precautions

Calmafx Moisture Barrier Product Label

The following document was submitted to the FDA by the labeler of this product First Choice Medical Supply. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

 calmafxtube.jpg


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