FDA.reportPublic FDA data

Elyptol Antimicrobial Rub

Manufacturer
Elyptol Inc. | 220 Laboratories LLC.
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:52:56

Label at a glance#

ProductElyptol Antimicrobial Rub
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

To decrease bacteria on skin. Recommended for repeated use.

Dosage and administration

• HAND SANITISER/SKIN ANTISEPTIC: Apply Elyptol evenly and rub for 30 seconds. • SURGICAL HAND DISINFECTION: Apply Elyptol from forearms to fingertips. Rub evenly for 3 minutes, including between fingers and over nails. • PRE-OPERATIVE SKIN PREPARATION AND SKIN ANTISEPSIS: Apply Elyptol and rub evenly over desired area for 30 seconds.

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Skin antiseptic

Keep out reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Supervise children under 6 years.
  • Not recommended for infants.

Uses

INDICATIONS & USAGE SECTION

  • To decrease bacteria on skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only

Flammable.

  • Keep away from sources of fire or flame.
  • If swallowed seek medical advice or contact a Poison Control Center, immediately.

When using this product

  • Do not ingest or inhale.
  • Keep away from eyes.
  • Use undiluted.

Stop using and ask a doctor

  • If redness or irritation develops.
  • In case of eye contact, rinse eyes with water.
  • If issues persist, seek medical attention.

Directions

DOSAGE & ADMINISTRATION SECTION

• HAND SANITISER/SKIN ANTISEPTIC: Apply Elyptol evenly and rub for 30 seconds.
• SURGICAL HAND DISINFECTION: Apply Elyptol from forearms to fingertips. Rub evenly for 3 minutes, including between fingers and over nails.
• PRE-OPERATIVE SKIN PREPARATION AND SKIN ANTISEPSIS: Apply Elyptol and rub evenly over desired area for 30 seconds.

Other Information

OTHER SAFETY INFORMATION

Store below 30°C
Keep out of direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus oil, Water, Glycerol, Cellulose, Piroctone Olamine.

SPL UNCLASSIFIED SECTION

INT PAT APP NO: PCT/2012/000841

Questions?

OTC - QUESTIONS SECTION

(866)701-8344

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN6
582753ethanol 0.7 ML/ML Topical SolutionSCD6
582753ethanol 70 % Topical SolutionSY6
582753ethyl alcohol 70 % Topical SolutionSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69343-221-022024-07-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-032024-07-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-082024-07-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-162024-07-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-342024-07-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-022024-01-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-032024-01-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-082024-01-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-162024-01-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub
69343-221-342024-01-30C16284748780-11030e365-1c38-111a-e063-dadaa90a10e2Elyptol Antimicrobial Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69343-221-02Elyptol Antimicrobial Rub59 mL in 1 BOTTLESOLUTION596
69343-221-02Elyptol Antimicrobial Rub1 in 1 CARTONSOLUTION16
69343-221-03Elyptol Antimicrobial Rub89 mL in 1 BOTTLESOLUTION896
69343-221-03Elyptol Antimicrobial Rub1 in 1 CARTONSOLUTION16
69343-221-08Elyptol Antimicrobial Rub1 in 1 CARTONSOLUTION16
69343-221-08Elyptol Antimicrobial Rub236 mL in 1 BOTTLESOLUTION2366
69343-221-16Elyptol Antimicrobial Rub473 mL in 1 BOTTLESOLUTION4736
69343-221-16Elyptol Antimicrobial Rub1 in 1 CARTONSOLUTION16
69343-221-34Elyptol Antimicrobial Rub1005 mL in 1 BOTTLESOLUTION10056
69343-221-34Elyptol Antimicrobial Rub1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69343-221ELYPTOL ANTIMICROBIAL RUB (ETHANOL) SOLUTION [ELYPTOL INC.]6Legacy NDC, 10 package rows20230105_a6903410-ab88-4634-9937-4b2d00e07915.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
PIROCTONE OLAMINEINACTIVE INGREDIENTA4V5C6R9FB1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69343-22169343-221-02, 69343-221-03, 69343-221-08, 69343-221-16, 69343-221-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
EUCALYPTUS OIL2R04ONI662IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT

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 2 · 76 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c47506d3-a699-4f9a-b9bd-6f26219d8fa0a6903410-ab88-4634-9937-4b2d00e079152022-12-19WarningsExact identifier
spl id: c47506d3-a699-4f9a-b9bd-6f26219d8fa0
spl set id: a6903410-ab88-4634-9937-4b2d00e07915

Reported adverse events (FAERS/openFDA)#

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