DERMA STAT- ethyl alcohol aerosol, foam

Derma Stat by

Drug Labeling and Warnings

Derma Stat by is a Otc medication manufactured, distributed, or labeled by Rosedale Therapeutics, LLC, 220 Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

65% Ethyl Alcohol by volume

PURPOSE

Antiseptic

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

SPL UNCLASSIFIED SECTION

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.

Packaging

INGREDIENTS AND APPEARANCE

DERMA STAT 
ethyl alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10802-8082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOBUTANE (UNII: BXR49TP611)
PROPANE (UNII: T75W9911L6)
WATER (UNII: 059QF0KO0R)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10802-8082-5	160 mL in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/16/2015

Labeler - Rosedale Therapeutics, LLC (161264622)

Establishment
Name	Address	ID/FEI	Business Operations
220 Laboratories Inc.		783247950	manufacture(10802-8082)