FDA.reportPublic FDA data

Novagel

Manufacturer
Nanova Biomaterials Inc
Effective date
2021-03-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:39:01

Label at a glance#

ProductNovaGel Wipes
Active ingredientALCOHOL
Label structure3 sections

Label contents#

Full prescribing information#

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Liquid Sanitizer SprayLiquid Sanitizer Spray

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v Antiseptic

Purpose Section

OTC - PURPOSE SECTION

Use - To decrease bacteria on skin

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Use - To decrease bacteria on skin

INDICATIONS & USAGE SECTION

Use - To decrease bacteria on skin

Warnings

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from fire and flame.

Dosage

DOSAGE & ADMINISTRATION SECTION

Active Ingredient

Ethyl Alcohol 80% v/v

Inactive Ingredient Section

Inactive Ingredients

Glycerin, Water

Hydra Pearl Wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydra Pearl Wipe LabelHydra Pearl Wipe Label

NovaGel Wipes Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NovaGel Wipes LabelNovaGel Wipes Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN4
1241663ethanol 0.8 ML/ML Topical SpraySCD4
1241663ethanol 80 % Topical SpraySY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80947-001-012022-07-29C16284748780-1e4f33bdf-a528-d8a0-e053-dadaa90a6e4eb2c2967a-0c17-5dd1-e053-2995a90afae3
80947-001-022022-07-29C16284748780-1e4f33bdf-a528-d8a0-e053-dadaa90a6e4eb2c2967a-0c17-5dd1-e053-2995a90afae3
80947-001-032022-07-29C16284748780-1e4f33bdf-a528-d8a0-e053-dadaa90a6e4eb2c2967a-0c17-5dd1-e053-2995a90afae3
80947-001-042022-07-29C16284748780-1e4f33bdf-a528-d8a0-e053-dadaa90a6e4eb2c2967a-0c17-5dd1-e053-2995a90afae3
80947-002-012022-07-29C16284748780-1e4f33bdf-a528-d8a0-e053-dadaa90a6e4eb2c2967a-0c17-5dd1-e053-2995a90afae3
80947-003-012022-07-29C16284748780-1e4f33bdf-a528-d8a0-e053-dadaa90a6e4eb2c2967a-0c17-5dd1-e053-2995a90afae3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80947-001-01Novagel3785 mL in 1 BOTTLESPRAY37854
80947-001-02Novagel946 mL in 1 BOTTLESPRAY9464
80947-001-03Novagel473 mL in 1 BOTTLESPRAY4734
80947-001-04Novagel908499 mL in 1 CONTAINERSPRAY9084994
80947-002-01Hydra Pearl Wipe700 mL in 1 CANISTERLIQUID7004
80947-003-01NovaGel Wipes700 mL in 1 CANISTERLIQUID7004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80947-001NOVAGEL WIPES (SANITIZING WIPES) LIQUID HYDRA PEARL WIPE (SANITIZING WIPE) LIQUID NOVAGEL (ANTISEPTIC SPRAY) SPRAY [NANOVA BIOMATERIALS INC]4Legacy NDC, 4 package rows20210317_b2c2967a-0c17-5dd1-e053-2995a90afae3.zip
80947-002NOVAGEL WIPES (SANITIZING WIPES) LIQUID HYDRA PEARL WIPE (SANITIZING WIPE) LIQUID NOVAGEL (ANTISEPTIC SPRAY) SPRAY [NANOVA BIOMATERIALS INC]4Legacy NDC, 1 package rows20210317_b2c2967a-0c17-5dd1-e053-2995a90afae3.zip
80947-003NOVAGEL WIPES (SANITIZING WIPES) LIQUID HYDRA PEARL WIPE (SANITIZING WIPE) LIQUID NOVAGEL (ANTISEPTIC SPRAY) SPRAY [NANOVA BIOMATERIALS INC]4Legacy NDC, 1 package rows20210317_b2c2967a-0c17-5dd1-e053-2995a90afae3.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80947-00380947-003-01
80947-00280947-002-01
80947-00180947-001-01, 80947-001-02, 80947-001-03, 80947-001-04

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
ALOEV5VD430YW9IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
ALOEV5VD430YW9IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
bd08be3a-3dd0-153b-e053-2995a90ac72ab2c2967a-0c17-5dd1-e053-2995a90afae32021-03-08WarningsExact identifier
spl id: bd08be3a-3dd0-153b-e053-2995a90ac72a
spl set id: b2c2967a-0c17-5dd1-e053-2995a90afae3

Reported adverse events (FAERS/openFDA)#

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