FDA Label for Derma Stat

View Indications, Usage & Precautions

Derma Stat Product Label

The following document was submitted to the FDA by the labeler of this product Rosedale Therapeutics, Llc. 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 Ingredient:



65% Ethyl Alcohol by volume


Otc - Purpose



Antiseptic


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Indications & Usage



Use: For hand washing to decrease bacteria on the skin.


Warnings



Warning: For external use only. Avoid contact with eyes. Contents under pressure. Do not puncture incinerate, use near fire, spark, flame, expose to heat or store above 120°F.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.


Dosage & Administration



Directions: Dispense approximately four grams (palm full) into palm of one hand. Spread thoroughly over both hands and gently rub into skin until dry. Repeat application as often as required. Washing hands with soap and water is recommended after approximately 15 applications.


Inactive Ingredients:



Emulsifying wax, Isobutane, Propane, Purified water, Tert-butyl alcohol


Other



DERMA STAT® Antimicrobial Waterless Hand Foam meets the recommended guidelines for use as a Health Care Personnel Hand Wash. Use to help meet OSHA standards. Recommended for repeated use.


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