FDA.reportPublic FDA data

Xanitize

Manufacturer
ICM Distributing Company, INC | Cospro Development Corp
Effective date
2020-05-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:11:11

Label at a glance#

ProductXanitize
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product in your palm to cover hands and rub hands 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 (43°C)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. 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 or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

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 occurs. These may be signs of a serious condition.
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 occurs. 

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 hands and rub hands 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 (43°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

deionized water, glycerin, polysorbate 20, aloe leaf juice, orange peel oil, tocopheryl acetate, maltodextrin, parfum

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77516-111-012022-01-28C16284748780-1d6a99b39-f285-a426-e053-dadaa90af4c281b1ae2a-f2d6-40aa-a2a3-3c654792c876
77516-111-022022-01-28C16284748780-1d6a99b39-f285-a426-e053-dadaa90af4c281b1ae2a-f2d6-40aa-a2a3-3c654792c876

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77516-111-01Xanitize242 mL in 1 BOTTLESOLUTION2421
77516-111-02Xanitize100 mL in 1 BOTTLESOLUTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77516-111XANITIZE (ALCOHOL) SOLUTION [ICM DISTRIBUTING COMPANY, INC]1Legacy NDC, 2 package rows20200514_81b1ae2a-f2d6-40aa-a2a3-3c654792c876.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77516-11177516-111-01, 77516-111-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
ALOEV5VD430YW9IACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
ORANGE PEELTI9T76XD44IACT
MALTODEXTRIN7CVR7L4A2DIACT

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
3c550150-307f-4265-8926-40599b21043e81b1ae2a-f2d6-40aa-a2a3-3c654792c8762020-05-13WarningsExact identifier
spl id: 3c550150-307f-4265-8926-40599b21043e
spl set id: 81b1ae2a-f2d6-40aa-a2a3-3c654792c876

Reported adverse events (FAERS/openFDA)#

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