FDA.reportPublic FDA data

freshnails

Manufacturer
TWB Strategic Investments Inc.
Effective date
2013-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:31

Label at a glance#

Productfreshnails the undernail sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Isopropyl Alcohol 70% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Use

  •  For antiseptic hand cleaning to kill and decrease germs and bacteria on the skin, particularly on the fingertip and under the fingernail area.
  •  For personal hand hygiene and recommended for repeated use.
  • Dries in seconds.

WARNINGS SECTION

Warnings

  •  Flammable. Keep away from open flame and sources of heat.
  •  For external use only.
  •  Keep out of reach of children.
  •  If digger (pick) is used, gently and carefully apply under fingernails.
  • Do not use if seal is broken.
  • Avoid contact with eyes, if contact occurs, flush with water.
  • Stop use and consult a healthcare professional if irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  •  Rub product onto fingertip skin and under fingernails and allow to dry.
  • Use as part of your daily cleansing routine.

INFORMATION FOR PATIENTS SECTION

Other Information

Store at room temperature: 15° - 30° (59° - 86° F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Ginseng (Panax Ginseng) Extract, Glycerin, Polysorbate 20, Purified Water, Tea Tree Essential Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN1
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD1
808520isopropyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58665-001-022019-11-27C16284748780-19855e2a2-3f12-60a7-e053-dbdaa90a05bdfreshnails

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58665-001-02freshnailsthe undernail sanitizer1 in 1 CARTONLIQUID11
58665-001-02freshnailsthe undernail sanitizer5.75 mL in 1 BOTTLE, WITH APPLICATORLIQUID5.751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58665-001FRESHNAILS THE UNDERNAIL SANITIZER (ISOPROPYL ALCOHOL) LIQUID [TWB STRATEGIC INVESTMENTS INC.]1Legacy NDC, 2 package rows20131119_b2a27fc1-dc98-432c-9442-e4d15bb72b20.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXI1
CUCUMBERINACTIVE INGREDIENTYY7C30VXJT1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1M1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YH1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58665-00158665-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CUCUMBERYY7C30VXJTIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C Yellow No. 5I753WB2F1MIACT
ASIAN GINSENGCUQ3A77YXIIACT
GLYCERINPDC6A3C0OXIACT
Polysorbate 207T1F30V5YHIACT
WATER059QF0KO0RIACT
TEA TREE OILVIF565UC2GIACT

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 3 · 162 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE, EXTENDED RELEASE / ORAL0.26 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, COATED / ORAL7.93 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, FILM COATED / ORAL1.68 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MSYRUP / ORAL0.1 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET / ORAL17 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MSUSPENSION / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact 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
b5fc2894-982e-4360-b0d6-d2e2b6661e55b2a27fc1-dc98-432c-9442-e4d15bb72b202013-11-18WarningsExact identifier
spl id: b5fc2894-982e-4360-b0d6-d2e2b6661e55
spl set id: b2a27fc1-dc98-432c-9442-e4d15bb72b20

Reported adverse events (FAERS/openFDA)#

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