FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
JinHua Denise Cosmetics CO., LTD.
Effective date
2020-05-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:25

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

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.

Storage and handling

*Do not store above 105°F.*May discolor some fabrica.*Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antisepic

Use

INDICATIONS & USAGE SECTION

*To decrease bacteria on the skin that could cause disease.
* Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only hands. Fammable. Keep away from heat or flame.When using this product *Keep out of eyes. In case of contact with eyes ,fiush 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.In case of accidental ingestion,seek professional assistance or contact a Poison Control Center immediately.

Do not use

OTC - DO NOT USE SECTION

Do not inhale or ingest. Stop use and ask a doctor if skin irritation develops.

OTC - WHEN USING SECTION

When using this product *Keep out of eyes. In case of contact with eyes ,fiush thoroughly with water. *Avoid contact with broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of accidental ingestion,seek professional assistance or contact a Poison Control Center immediately.

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

STORAGE AND HANDLING SECTION

*Do not store above 105°F.*May discolor some fabrica.*Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua), Glycerin, Triethanolamine, Carbomer, Aloe
Barbadensis Leaf Extract, Propylene Glycol,Tocopheryl Acetate (Vitamin E).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3030

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
77663-005-012021-07-23C16284748780-1c7ccaba7-22ad-fd44-e053-dadaa90aa01bHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77663-005-01Hand Sanitizer30 mL in 1 BOTTLEGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77663-005HAND SANITIZER GEL [JINHUA DENISE COSMETICS CO., LTD.]1Legacy NDC, 1 package rows20200524_a64f8372-f40c-c4c8-e053-2a95a90a7283.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
77663-00577663-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
a64f8372-f3fc-c4c8-e053-2a95a90a7283a64f8372-f40c-c4c8-e053-2a95a90a72832020-05-23WarningsExact identifier
spl id: a64f8372-f3fc-c4c8-e053-2a95a90a7283
spl set id: a64f8372-f40c-c4c8-e053-2a95a90a7283

Reported adverse events (FAERS/openFDA)#

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