FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SKYMAX VIETNAM COMPANY LIMITED
Effective date
2021-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:52

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

We hands thoroughly with product Brisky rub hands together until dry Supervise children under 6 years in the use of this product.

Storage and handling

May discolor certain fabrics Store at the normal temperature

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Recommended for repeated use.

For handwashing 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. In case of contact, rinse eyes thoroughly with water

OTC - WHEN USING SECTION

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

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. These may be signs of a serious condition.

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

  • We hands thoroughly with product
  • Brisky rub hands together until dry
  • Supervise children under 6 years in the use of this product.

Other information

STORAGE AND HANDLING SECTION

  • May discolor certain fabrics
  • Store at the normal temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua, carbomer 940, trolamine, hydro peroxide, glycerin, fragrance, vitamin e

RECENT MAJOR CHANGES SECTION

Indications and Usage: Change wordings

Directions: Change wordings

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 81650-100- 01

81650-100-0181650-100-01

250 mL NDC: 81650-100- 02

81650-100-0281650-100-02

500 mL NDC: 81650-100- 03

81650-100-0381650-100-03

1000 mL NDC: 81650-100- 04

81650-100-0481650-100-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN2
2277550ethanol 0.72 ML/ML Topical GelSCD2
2277550ethanol 72 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81650-100-012022-07-29C16284748780-1e4f33bdf-a83e-d8a0-e053-dadaa90a6e4ebc99ad3c-e8bd-355d-e053-2995a90af783
81650-100-022022-07-29C16284748780-1e4f33bdf-a83e-d8a0-e053-dadaa90a6e4ebc99ad3c-e8bd-355d-e053-2995a90af783
81650-100-032022-07-29C16284748780-1e4f33bdf-a83e-d8a0-e053-dadaa90a6e4ebc99ad3c-e8bd-355d-e053-2995a90af783
81650-100-042022-07-29C16284748780-1e4f33bdf-a83e-d8a0-e053-dadaa90a6e4ebc99ad3c-e8bd-355d-e053-2995a90af783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81650-100-01Hand Sanitizer100 mL in 1 BOTTLEGEL1002
81650-100-02Hand Sanitizer250 mL in 1 BOTTLEGEL2502
81650-100-03Hand Sanitizer500 mL in 1 BOTTLEGEL5002
81650-100-04Hand Sanitizer1000 mL in 1 BOTTLEGEL10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81650-100HAND SANITIZER (ALCOHOL) GEL [SKYMAX VIETNAM COMPANY LIMITED]2Legacy NDC, 4 package rows20210311_bc99ad3c-e8bd-355d-e053-2995a90af783.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
81650-10081650-100-01, 81650-100-02, 81650-100-03, 81650-100-04

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
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
bd2d080a-b76d-e241-e053-2995a90aeefabc99ad3c-e8bd-355d-e053-2995a90af7832021-03-10WarningsExact identifier
spl id: bd2d080a-b76d-e241-e053-2995a90aeefa
spl set id: bc99ad3c-e8bd-355d-e053-2995a90af783

Reported adverse events (FAERS/openFDA)#

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