FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SHANDISHI Biological Technology Co., Ltd.
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:57

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

For Hand Sanitizing

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping●For children under 6 use only under adult Supervision.●Not recommended for infants.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For Hand Sanitizing

Warnings

WARNINGS SECTION

Warnings: For external use only-hands.
Flammable: Keep away from heat and flame.
When using this product Keep out of eyes. In case of
contact with eyes, flush thoroughly with water.●Avoid contact with
broken skin.●Do not inhale or ingest.
Stop use and ask a doctor
if skin irritation develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or call a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to
dry without wiping●For children under 6 use only under adult
Supervision.●Not recommended for infants.

Other information

SPL UNCLASSIFIED SECTION

1 Do not store above 105°F
1 May discolor some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl
Acetate, Triethanolamine, Water.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77753-004-012022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-022022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-032022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-042022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-052022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-062022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-072022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-082022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-092022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-102022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-112022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-122022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-132022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol
77753-004-142022-01-28C16284748780-1d6a99b39-5a24-a426-e053-dadaa90af4c277753-004 ​Hand Sanitizer 70% Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77753-004-01Hand Sanitizer12 in 1 BOXGEL121
77753-004-01Hand Sanitizer10 mL in 1 BOTTLEGEL101
77753-004-02Hand Sanitizer15 mL in 1 BOTTLEGEL151
77753-004-02Hand Sanitizer12 in 1 BOXGEL121
77753-004-03Hand Sanitizer30 mL in 1 BOTTLEGEL301
77753-004-03Hand Sanitizer12 in 1 BOXGEL121
77753-004-04Hand Sanitizer53 mL in 1 BOTTLEGEL531
77753-004-04Hand Sanitizer12 in 1 BOXGEL121
77753-004-05Hand Sanitizer60 mL in 1 BOTTLEGEL601
77753-004-05Hand Sanitizer12 in 1 BAGGEL121
77753-004-06Hand Sanitizer120 mL in 1 BOTTLEGEL1201
77753-004-06Hand Sanitizer8 in 1 BOXGEL81
77753-004-07Hand Sanitizer8 in 1 BOXGEL81
77753-004-07Hand Sanitizer236 mL in 1 BOTTLEGEL2361
77753-004-08Hand Sanitizer8 in 1 BOXGEL81
77753-004-08Hand Sanitizer250 mL in 1 BOTTLEGEL2501
77753-004-09Hand Sanitizer4 in 1 BOXGEL41
77753-004-09Hand Sanitizer473 mL in 1 BOTTLEGEL4731
77753-004-10Hand Sanitizer4 in 1 BOXGEL41
77753-004-10Hand Sanitizer500 mL in 1 BOTTLEGEL5001
77753-004-11Hand Sanitizer120 mL in 1 BOTTLEGEL1201
77753-004-11Hand Sanitizer12 in 1 BOXGEL121
77753-004-12Hand Sanitizer4 in 1 BOXGEL41
77753-004-12Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
77753-004-13Hand Sanitizer4 in 1 BOXGEL41
77753-004-13Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
77753-004-14Hand Sanitizer4 in 1 BOXGEL41
77753-004-14Hand Sanitizer3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77753-004HAND SANITIZER (ETHYL ALCOHOL) GEL [SHANDISHI BIOLOGICAL TECHNOLOGY CO., LTD.]1Legacy NDC, 28 package rows20200610_a7b1c019-b5a8-ca9d-e053-2a95a90a7724.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77753-00477753-004-01, 77753-004-02, 77753-004-03, 77753-004-04, 77753-004-05, 77753-004-06, 77753-004-07, 77753-004-08, 77753-004-09, 77753-004-10, 77753-004-11, 77753-004-12, 77753-004-13, 77753-004-14

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
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
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
a7b22505-52d9-47fd-e053-2995a90a77b3a7b1c019-b5a8-ca9d-e053-2a95a90a77242020-06-09WarningsExact identifier
spl id: a7b22505-52d9-47fd-e053-2995a90a77b3
spl set id: a7b1c019-b5a8-ca9d-e053-2a95a90a7724

Reported adverse events (FAERS/openFDA)#

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