Derma Stat

Manufacturer: Rosedale Therapeutics, LLC | 220 Laboratories Inc.
Effective date: 2015-02-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:42:34

Label at a glance#

ProductDerma Stat

Active ingredientALCOHOL

Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

65% Ethyl Alcohol by volume

OTC - PURPOSE SECTION

Antiseptic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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 SECTION

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:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199130	ethanol 65 % Topical Foam	PSN	1
199130	ethanol 0.65 ML/ML Topical Foam	SCD	1
199130	ethanol 65 % Topical Foam	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10802-8082-5	2020-01-31	C162847	48780-1	9d75b9d0-4540-f424-e053-dadaa90a57ce	Derma Stat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10802-8082-5	Derma Stat	160 mL in 1 CAN	AEROSOL, FOAM	160		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10802-8082	DERMA STAT (ETHYL ALCOHOL) AEROSOL, FOAM [ROSEDALE THERAPEUTICS, LLC]	1	Legacy NDC, 1 package rows	20150522_5769bbc0-b297-4fec-81ae-e6fdf29c5f7f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10802-8082-5	ML - Milliliter	10802-8082	13fe1802-c0e4-4b36-979d-28e3841dddcc	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
ISOBUTANE	INACTIVE INGREDIENT	BXR49TP611	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	1
PROPANE	INACTIVE INGREDIENT	T75W9911L6	1
TERT-BUTYL ALCOHOL	INACTIVE INGREDIENT	MD83SFE959	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Derma Stat
Ethyl alcohol
ALCOHOL
CETOSTEARYL ALCOHOL
POLYSORBATE 60
ISOBUTANE
PROPANE
WATER
TERT-BUTYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10802-8082	10802-8082-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
ISOBUTANE	BXR49TP611	IACT
PROPANE	T75W9911L6	IACT
WATER	059QF0KO0R	IACT
TERT-BUTYL ALCOHOL	MD83SFE959	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 29 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPANE	PROPANE	T75W9911L6	AEROSOL, FOAM / TOPICAL	55 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	OINTMENT / TOPICAL	2 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	EMULSION / ORAL	20 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, FOAM / RECTAL		142 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
TERT-BUTYL ALCOHOL	TERT-BUTYL ALCOHOL	MD83SFE959	GEL / TOPICAL	0.12 %w/w		Exact identifier — unii candidate
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	AEROSOL, FOAM / TOPICAL		30 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, SPRAY / TOPICAL		4484 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / TOPICAL		225 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, FOAM / TOPICAL	18 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / RECTAL	0.05 mg/mg		Exact identifier — unii candidate 13 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
PROPANE	PROPANE	T75W9911L6	AEROSOL, FOAM / RECTAL		9 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / VAGINAL	0.03 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL / TOPICAL		4484 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / TOPICAL	2.85 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bbd67a43-d0e6-418e-8b8d-8abf8f021f60			5769bbc0-b297-4fec-81ae-e6fdf29c5f7f	2015-02-16	Warnings	Exact identifier spl id: bbd67a43-d0e6-418e-8b8d-8abf8f021f60 spl set id: 5769bbc0-b297-4fec-81ae-e6fdf29c5f7f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.