FDA.reportPublic FDA data

Novogel

Manufacturer
KEY QUIMICA S.A. DE C.V.
Effective date
2021-03-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:49:22

Label at a glance#

ProductNovogel
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

To decrease bacteria on skin that could cause diseases. Recommended for reapeted use.

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on skin that could cause diseases. Recommended for reapeted use.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

this product in or near the eyes.

OTC - STOP USE SECTION

Stop use if irritation or redness develop. If condition persists for more than 72 hours, consult a doctoer.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek immediate medical attention or call a poison control center.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), glycerin, carbomer, triethanolamine, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benzoate.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NovogelNovogel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Novogel X4Novogel X4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Novogel UXNovogel UX

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58345-10058345-100-01, 58345-100-02, 58345-100-03, 58345-100-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DENATONIUM BENZOATE ANHYDROUSM5BA6GAF1OIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
GLYCERETH-7 TRIACETATES9W6Z48HUPIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT

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
177d1d8c-4f60-a0fd-e063-6294a90a086fac3a1009-1646-57ce-e053-2995a90a6fcb2024-05-02WarningsExact identifier
spl set id: ac3a1009-1646-57ce-e053-2995a90a6fcb

Reported adverse events (FAERS/openFDA)#

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