FDA.reportPublic FDA data

Intelliwrist Personal Hand Sanitizer

Manufacturer
Intelwrist, LLC
Effective date
2023-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:43

Label at a glance#

ProductIntelliwrist Personal Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 yeras of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient(s)

Ethyl acohol 70% v/v...................

Purpose

OTC - PURPOSE SECTION

Purpose

Antiseptic

Use

INDICATIONS & USAGE SECTION

Use

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

Do not use

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

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical lhelp or contact a Poison Control Cernter right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 yeras of age when using this product to avoid swallowing.

Other Information

OTHER SAFETY INFORMATION

Other Information

  • store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, glycerin, fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

83135-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83135-001-02 LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83135-001-012025-01-30C16284748780-11030e365-1b50-111a-e063-dadaa90a10e2Intelliwrist Personal Hand Sanitizer
83135-001-022025-01-30C16284748780-11030e365-1b50-111a-e063-dadaa90a10e2Intelliwrist Personal Hand Sanitizer
83135-001-012024-08-15C16284748780-11030e365-1b50-111a-e063-dadaa90a10e2Intelliwrist Personal Hand Sanitizer
83135-001-022024-08-15C16284748780-11030e365-1b50-111a-e063-dadaa90a10e2Intelliwrist Personal Hand Sanitizer
83135-001-012024-07-30C16284748780-11030e365-1b50-111a-e063-dadaa90a10e2Intelliwrist Personal Hand Sanitizer
83135-001-022024-07-30C16284748780-11030e365-1b50-111a-e063-dadaa90a10e2Intelliwrist Personal Hand Sanitizer
83135-001-012024-01-30C16284748780-11030e365-1b50-111a-e063-dadaa90a10e2Intelliwrist Personal Hand Sanitizer
83135-001-022024-01-30C16284748780-11030e365-1b50-111a-e063-dadaa90a10e2Intelliwrist Personal Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83135-001-01Intelliwrist Personal Hand Sanitizer40 mL in 1 KITLIQUID403
83135-001-02Intelliwrist Personal Hand Sanitizer40 mL in 1 BOXLIQUID403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83135-001INTELLIWRIST PERSONAL HAND SANITIZER (TOPICAL ANTISEPTIC) LIQUID [INTELWRIST, LLC]3Legacy NDC, 2 package rows20230415_eeb25c11-9a9d-5b8e-e053-2a95a90a6363.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83135-00183135-001-01, 83135-001-02

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
FRAGRANCE 135765EM498GW35IACT

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
f2f3e25c-e005-cc20-e053-2a95a90a7569eeb25c11-9a9d-5b8e-e053-2a95a90a63632023-01-23WarningsExact identifier
spl id: f2f3e25c-e005-cc20-e053-2a95a90a7569
spl set id: eeb25c11-9a9d-5b8e-e053-2a95a90a6363

Reported adverse events (FAERS/openFDA)#

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