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Derma Stat

Dosage form: aerosol, foam
Ingredients: ALCOHOL 65mL in 100mL
Labeler: Rosedale Therapeutics, LLC
NDC Code: 10802-8082

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Derma Stat

Active Ingredient:

65% Ethyl Alcohol by volume

Antiseptic

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

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

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.

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

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

DERMA STAT 
ethyl alcohol aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10802-8082
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
ISOBUTANE 
PROPANE 
WATER 
TERT-BUTYL ALCOHOL 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10802-8082-5160 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/16/2015
Labeler - Rosedale Therapeutics, LLC (161264622)
Establishment
NameAddressID/FEIOperations
220 Laboratories Inc.783247950manufacture(10802-8082)

Revised: 02/2015
 
Rosedale Therapeutics, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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