FDA.reportPublic FDA data

Deljine Hand Sanitizer gel

Manufacturer
Deljine Cosmetics corporation
Effective date
2020-08-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:25:26

Label at a glance#

ProductDeljine Hand Sanitizer gel
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol (Ethanol)-70 % V/V / Alcool Ethylique 70% V/V

Purpose

OTC - PURPOSE SECTION

Antibacterial (skin) cleanser. Antiseptic (skin) cleanser. Effective in destroying (harmful) bacteria to provide antiseptic cleansing.

Use

INDICATIONS & USAGE SECTION

For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria/germs. Medicated (skin) cleanser. For use when soap and water are not available.

RECENT MAJOR CHANGES SECTION

For personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria/germs. Medicated (skin) cleanser. For use when soap and water are not available.

Warnings

WARNINGS SECTION

Flammability warning. Keep away from open flame and sources of heat. For external use only.

Do not use

OTC - DO NOT USE SECTION

  • Do not use on children/infants less than 2 years of age (unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional). Do not use on open skin wounds

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation or rash develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.

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

Water/ Aqua/Eau , Ammonium Acryloyldimethyltaurate, Glycerin, Aloe Barbadensis Leaf Juice, d-alpha-tochopheryl Acetate, fragrance (green tea coriander and mandarin)/ parfum (thé vert coriandre et mandarine).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 78064-001-10NDC: 78064-001-10Hand sanitizer gel 1000 ml, NDC: 78064-001-10

Hand sanitizer 3.78 LHand sanitizer 3.78 L

78064-001-0278064-001-02

78064-001-0178064-001-01

front label of sparyfront label of spary

78064-002-02

back of label sprayback of label spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
1041849ethanol 70 % Topical SprayPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
1041849ethanol 0.7 ML/ML Topical SpraySCD3
581662ethanol 70 % Topical GelSY3
1041849ethanol 70 % Topical SpraySY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78064-001-012022-01-28C16284748780-1d6a99b39-601e-a426-e053-dadaa90af4c2Hand sanitizer
78064-001-022022-01-28C16284748780-1d6a99b39-601e-a426-e053-dadaa90af4c2Hand sanitizer
78064-001-102022-01-28C16284748780-1d6a99b39-601e-a426-e053-dadaa90af4c2Hand sanitizer
78064-001-402022-01-28C16284748780-1d6a99b39-601e-a426-e053-dadaa90af4c2Hand sanitizer
78064-002-022022-01-28C16284748780-1d6a99b39-601e-a426-e053-dadaa90af4c2Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78064-001-01Deljine Hand Sanitizer gel100 mL in 1 BOTTLE, PLASTICGEL1003
78064-001-02Deljine Hand Sanitizer gel200 mL in 1 BOTTLE, PUMPGEL2003
78064-001-10Deljine Hand Sanitizer gel1000 mL in 1 BOTTLE, PLASTICGEL10003
78064-001-40Deljine Hand Sanitizer gel3780 mL in 1 BOTTLE, PLASTICGEL37803
78064-002-02deljine hand sanitizer236.6 mL in 1 BOTTLE, SPRAYSPRAY236.63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78064-001DELJINE HAND SANITIZER GEL (ALCOHOL) GEL DELJINE HAND SANITIZER (ALCOHOL) SPRAY [DELJINE COSMETICS CORPORATION]3Legacy NDC, 4 package rows20200822_a8178030-b4c4-eec0-e053-2a95a90a357c.zip
78064-002DELJINE HAND SANITIZER GEL (ALCOHOL) GEL DELJINE HAND SANITIZER (ALCOHOL) SPRAY [DELJINE COSMETICS CORPORATION]3Legacy NDC, 1 package rows20200822_a8178030-b4c4-eec0-e053-2a95a90a357c.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
78064-00178064-001-02, 78064-001-10, 78064-001-01, 78064-001-40
78064-00278064-002-02

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
GLYCERINPDC6A3C0OXIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S)LZ291VH90HIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT

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
ad65bc1c-1408-69cb-e053-2995a90ab67fa8178030-b4c4-eec0-e053-2a95a90a357c2020-08-21WarningsExact identifier
spl id: ad65bc1c-1408-69cb-e053-2995a90ab67f
spl set id: a8178030-b4c4-eec0-e053-2a95a90a357c

Reported adverse events (FAERS/openFDA)#

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