FDA Label for Calmodrox

View Indications, Usage & Precautions

Calmodrox Product Label

The following document was submitted to the FDA by the labeler of this product Geritrex Corp. 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.

Drug Facts



Active Ingredient                       Purpose

Menthol 0.44%                     External analgesic

                                           First aid antiseptic antipruritic

Zinc Oxide 20.0%                 Skin protectant/moisture barrier


Uses



A moisture barrier that prevents and helps heal skin irritation from Urine, diarrhea, perspiration, fistula drainge, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching


Directions



Cleanse skin gently with mild skin cleanser. Pet dry or allow to air dry. Apply a thin layer of Calmodrox 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


Warnings



FOR EXTERNAL USE ONLY

Not for deep or puncture wounds

Avoid contact with eyes

If condition worsens or does not improve within 7 days, consult a doctor


Inactive Ingredients



Calamine, DMDM Hydantoin, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Phenol, Propylparaben, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearyl Alcohol, Sorbitan Sesquioleate, Sodium bicarbonate and Thymol


Keep Out Of Reach Of Children



In the event of accidental ingestion contact a Poison Control Center right away


Storage



Store at room temperature 15°-30°C (59°-86°F)


Dosage & Administration



Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily.


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