FDA.reportPublic FDA data

Zany Antiseptic Gel

Manufacturer
Laboratorios Zepol S.A.
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:12

Label at a glance#

ProductZany Antiseptic Gel
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • irritation and redness develop 
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • Store below 86°F (30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, fragrance, triethanolamine, water.

Package Labeling:120ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBoxBottleBottle

Package Labeling:250ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box2Box2Bottle2Bottle2

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box3Box3Bottle3Bottle3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55715-004-01Zany Antiseptic Gel120 mL in 1 BOTTLE, WITH APPLICATORGEL1202
55715-004-02Zany Antiseptic Gel250 mL in 1 BOTTLE, WITH APPLICATORGEL2502
55715-004-03Zany Antiseptic Gel500 mL in 1 BOTTLE, WITH APPLICATORGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55715-004ZANY ANTISEPTIC GEL (ALCOHOL) GEL [LABORATORIOS ZEPOL S.A.]2Current NDC, Legacy NDC, 3 package rows20231202_ee085cb5-0ebf-498c-b622-b2c29d34bb9b.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55715-00455715-004-01, 55715-004-02, 55715-004-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
ndc (package): 55715-004-01
ndc (package): 55715-004-02
ndc (package): 55715-004-03
ndc (product): 55715-004
ndc11 (package): 55715000402
ndc11 (package): 55715000401
ndc11 (package): 55715000403
spl id: 0b7653e2-ce90-c9a8-e063-6394a90a814c
spl set id: ee085cb5-0ebf-498c-b622-b2c29d34bb9b

Reported adverse events (FAERS/openFDA)#

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