FDA.reportPublic FDA data

Advanced Hand Sanitizer

Manufacturer
SHENZHEN HYDROXY TECHNOLOGY CO.,LTD
Effective date
2021-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:40

Label at a glance#

ProductAdvanced Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Advanced Hand Sanitizer

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat 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 keep out of eyes, ears, and mouth. In case of contact with eyes, 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. 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

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer
Deionized water
Glycerin
PCMX
Triethanolamine
Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20002000500050005050606025025010001000300300750750100100500500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81477-101-012022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-022022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-032022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-042022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-052022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-062022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-072022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-082022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-092022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer
81477-101-102022-07-29C16284748780-1e4f33bdf-b019-d8a0-e053-dadaa90a6e4eAdvanced Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81477-101-01Advanced Hand Sanitizer50 mL in 1 BOTTLEGEL502
81477-101-02Advanced Hand Sanitizer60 mL in 1 BOTTLEGEL602
81477-101-03Advanced Hand Sanitizer100 mL in 1 BOTTLEGEL1002
81477-101-04Advanced Hand Sanitizer250 mL in 1 BOTTLEGEL2502
81477-101-05Advanced Hand Sanitizer300 mL in 1 BOTTLEGEL3002
81477-101-06Advanced Hand Sanitizer500 mL in 1 BOTTLEGEL5002
81477-101-07Advanced Hand Sanitizer750 mL in 1 BOTTLEGEL7502
81477-101-08Advanced Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
81477-101-09Advanced Hand Sanitizer2000 mL in 1 BOTTLEGEL20002
81477-101-10Advanced Hand Sanitizer5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81477-101ADVANCED HAND SANITIZER (ALCOHOL) GEL [SHENZHEN HYDROXY TECHNOLOGY CO.,LTD]2Legacy NDC, 10 package rows20210203_ba44955c-177c-e616-e053-2a95a90a1ce6.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
81477-10181477-101-01, 81477-101-02, 81477-101-03, 81477-101-04, 81477-101-05, 81477-101-06, 81477-101-07, 81477-101-08, 81477-101-09, 81477-101-10

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
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
CHLOROXYLENOL0F32U78V2QIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT

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
ba528d65-0f06-86b5-e053-2995a90aab59ba44955c-177c-e616-e053-2a95a90a1ce62021-02-01WarningsExact identifier
spl id: ba528d65-0f06-86b5-e053-2995a90aab59
spl set id: ba44955c-177c-e616-e053-2a95a90a1ce6

Reported adverse events (FAERS/openFDA)#

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