FDA.reportPublic FDA data

Xanitize

Manufacturer
Cospro Development Corp
Effective date
2021-05-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:40:14

Label at a glance#

ProductXanitize
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product in your palm to cover hand and rub together briskly until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store below 110° F (43º)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) 
  2. Glycerol.
  3. Sterile distilled water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • do not use in or near eyes

OTC - WHEN USING SECTION

When using this product do not use in or near eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • Place enough product in your palm to cover hand and rub together briskly until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110° F (43º)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, tocopheryl acetate, purified water, aloe barbadensis leaf juice, maltodextrin, citrus aurantium dulcis peel oil, acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Principle display label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN5
582753ethanol 0.7 ML/ML Topical SolutionSCD5
582753ethanol 70 % Topical SolutionSY5
582753ethyl alcohol 70 % Topical SolutionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46607-114-012022-07-29C16284748780-1e4f33bdf-9dbe-d8a0-e053-dadaa90a6e4e31419e08-9b2d-4607-88f3-111270fabd9d
46607-114-022022-07-29C16284748780-1e4f33bdf-9dbe-d8a0-e053-dadaa90a6e4e31419e08-9b2d-4607-88f3-111270fabd9d
46607-114-032022-07-29C16284748780-1e4f33bdf-9dbe-d8a0-e053-dadaa90a6e4e31419e08-9b2d-4607-88f3-111270fabd9d
46607-114-042022-07-29C16284748780-1e4f33bdf-9dbe-d8a0-e053-dadaa90a6e4e31419e08-9b2d-4607-88f3-111270fabd9d
46607-114-052022-07-29C16284748780-1e4f33bdf-9dbe-d8a0-e053-dadaa90a6e4e31419e08-9b2d-4607-88f3-111270fabd9d
46607-114-062022-07-29C16284748780-1e4f33bdf-9dbe-d8a0-e053-dadaa90a6e4e31419e08-9b2d-4607-88f3-111270fabd9d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46607-114-01Xanitize242 mL in 1 BOTTLESOLUTION2425
46607-114-02Xanitize59 mL in 1 BOTTLESOLUTION595
46607-114-03Xanitize946 mL in 1 BOTTLESOLUTION9465
46607-114-04Xanitize88 mL in 1 BOTTLESOLUTION885
46607-114-05Xanitize473 mL in 1 BOTTLESOLUTION4735
46607-114-06Xanitize662 mL in 1 BOTTLESOLUTION6625

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46607-114XANITIZE (ALCOHOL) SOLUTION [COSPRO DEVELOPMENT CORP]5Legacy NDC, 6 package rows20210509_31419e08-9b2d-4607-88f3-111270fabd9d.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
46607-11446607-114-01, 46607-114-05, 46607-114-06, 46607-114-02, 46607-114-03, 46607-114-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ORANGE PEELTI9T76XD44IACT
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERB9J55EA6QXIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

Source Document#

Source XML · Source PDF

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
01c3cad7-2e77-4a33-a4dc-1601663c72b031419e08-9b2d-4607-88f3-111270fabd9d2021-05-05WarningsExact identifier
spl id: 01c3cad7-2e77-4a33-a4dc-1601663c72b0
spl set id: 31419e08-9b2d-4607-88f3-111270fabd9d

Reported adverse events (FAERS/openFDA)#

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