FDA.reportPublic FDA data

ZANILAST+ GEL 70% ALCOHOL

Manufacturer
Nanomateriales, S.A. de C.V.
Effective date
2020-07-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:20:59

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping

Storage and handling

Store between 59-86ºF (15-30ºC) Avoid freezing and excessive heat above (40ºC) 104ºF

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

OTC - PURPOSE SECTION

Purpose: 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 heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop. Condition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

STORAGE AND HANDLING SECTION

  • Store between 59-86ºF (15-30ºC)
  • Avoid freezing and excessive heat above (40ºC) 104ºF

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, glycerin, fragrance, triethanolamine, water, zinc oxide, zinc pyrithione

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200000 mL NDC 69912-009-06

200L200L

60 mL NDC 69912-009-05

60mL60mL

500 mL NDC 69912-009-03

500mL500mL

250 mL NDC 69912-009-04

250mL250mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69912-009-032022-01-28C16284748780-1d6a99b39-aae0-a426-e053-dadaa90af4c2ZANILAST+ GEL 70% ALCOHOL
69912-009-042022-01-28C16284748780-1d6a99b39-aae0-a426-e053-dadaa90af4c2ZANILAST+ GEL 70% ALCOHOL
69912-009-052022-01-28C16284748780-1d6a99b39-aae0-a426-e053-dadaa90af4c2ZANILAST+ GEL 70% ALCOHOL
69912-009-062022-01-28C16284748780-1d6a99b39-aae0-a426-e053-dadaa90af4c2ZANILAST+ GEL 70% ALCOHOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69912-009-03Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5002
69912-009-04Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2502
69912-009-05Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL602
69912-009-06Hand Sanitizer200000 mL in 1 BOTTLE, PLASTICGEL2000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69912-009HAND SANITIZER (ALCOHOL) GEL [NANOMATERIALES, S.A. DE C.V.]2Legacy NDC, 4 package rows20200711_aa19e8fd-302e-fe93-e053-2995a90aa870.zip

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
69912-00969912-009-06, 69912-009-05, 69912-009-03, 69912-009-04

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
ZINC OXIDESOI2LOH54ZIACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
LIMONENE, (+)-GFD7C86Q1WIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
PYRITHIONE ZINCR953O2RHZ5IACT

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
aa1d95fe-0d7b-927a-e053-2a95a90af6f1aa19e8fd-302e-fe93-e053-2995a90aa8702020-07-10WarningsExact identifier
spl id: aa1d95fe-0d7b-927a-e053-2a95a90af6f1
spl set id: aa19e8fd-302e-fe93-e053-2995a90aa870

Reported adverse events (FAERS/openFDA)#

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