FDA.reportPublic FDA data

INSTANT HAND SANITISER GEL

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#

ProductINSTANT HAND SANITISER
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. No rinsing required, For children under 6, use only under adult supervision. Not recommended for infants.

Storage and handling

Store below 105°F (40 °C). May discolor certain fabrics. Harmful to wood finishes & 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. When water, soap and towel are not available. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only hands. Fammable. Keep away from fire or flame.When using this product Keep out of eyes, ears, or mouth. In case of eye
contact, fiush eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
Stop use and ask a doctor if rednes or irritation develop. condition persists for more than 72 hours.
Keep out of reach of children
Children should be supervised by an adult when using this product. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

Do not inhale or ingest

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rednes or irritation develop. condition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
Children should be supervised by an adult when using this product. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping. No rinsing required, For children under 6, use only under adult supervision. Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

Store below 105°F (40 °C). May discolor certain fabrics. Harmful to wood finishes & plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60603030100100

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
77663-006-012021-07-23C16284748780-1c7ccaba7-1f11-fd44-e053-dadaa90aa01bINSTANT HAND SANITISER GEL
77663-006-022021-07-23C16284748780-1c7ccaba7-1f11-fd44-e053-dadaa90aa01bINSTANT HAND SANITISER GEL
77663-006-032021-07-23C16284748780-1c7ccaba7-1f11-fd44-e053-dadaa90aa01bINSTANT HAND SANITISER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77663-006-01INSTANT HAND SANITISER30 mL in 1 BOTTLEGEL301
77663-006-02INSTANT HAND SANITISER60 mL in 1 BOTTLEGEL601
77663-006-03INSTANT HAND SANITISER100 mL in 1 BOTTLEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77663-006INSTANT HAND SANITISER GEL [JINHUA DENISE COSMETICS CO., LTD.]1Legacy NDC, 3 package rows20200524_a64ff4e1-d595-8508-e053-2995a90aa098.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77663-00677663-006-01, 77663-006-02, 77663-006-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT

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
a64fe612-c966-85aa-e053-2995a90a435da64ff4e1-d595-8508-e053-2995a90aa0982020-05-23WarningsExact identifier
spl id: a64fe612-c966-85aa-e053-2995a90a435d
spl set id: a64ff4e1-d595-8508-e053-2995a90aa098

Reported adverse events (FAERS/openFDA)#

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