FDA.reportPublic FDA data

CALA ADVANCED HAND SANITIZER

Manufacturer
David Cosmetic Co Ltd
Effective date
2021-10-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:43

Label at a glance#

ProductCALA ADVANCED HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Other Information  ▪ Store between 15°C to 30°C(59°F to 86°F) ▪ Avoid freezing and excessive heat above 40°C(104°F)

Label contents#

Full prescribing information#

Active Ingredient [s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

▪ to reduce bacteria on the skin that could cause disease ▪ recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame.

Do not use ▪ in children less than 2 months of age ▪ on open skin wounds

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.

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.

DOSAGE & ADMINISTRATION SECTION

​Directions ▪ 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 SECTION

Other Information ▪ Store between 15°C to 30°C(59°F to 86°F) ▪ Avoid freezing and excessive heat above 40°C(104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Butylene Glycol, 1,2-Hexanediol, Menthol

Questions or Comments?

OTC - QUESTIONS SECTION

1-213-745-5141

SPL UNCLASSIFIED SECTION

Gel Hydratant Aloe Vera

√ Deep Moisturizing

√ Non-Sticky

MOISTURISING & REFRESHING

KILLS HARMFUL GERM ON THE SKIN!

MADE IN KOREA

CALA® PRODUCTS

LOS ANGELES, CA 90007, U.S.A.

www.calaproduct.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cala1Cala1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58241-0009-12022-07-29C16284748780-1c7ccaba7-1c32-fd44-e053-dadaa90aa01ba96e7100-4ba9-1e45-e053-2a95a90ab0c9
58241-0009-12021-10-13C16284748780-1c7ccaba7-1c32-fd44-e053-dadaa90aa01ba96e7100-4ba9-1e45-e053-2a95a90ab0c9
58241-0009-12021-07-23C16284748780-1c7ccaba7-1c32-fd44-e053-dadaa90aa01ba96e7100-4ba9-1e45-e053-2a95a90ab0c9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58241-0009-1CALA ADVANCED HAND SANITIZER500 mL in 1 BOTTLE, PUMPGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58241-0009CALA ADVANCED HAND SANITIZER (ALCOHOL) GEL [DAVID COSMETIC CO LTD]2Legacy NDC, 1 package rows20211014_a96e7100-4ba9-1e45-e053-2a95a90ab0c9.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
58241-000958241-0009-1

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
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
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
ce391429-cedb-6616-e053-2995a90a1b17a96e7100-4ba9-1e45-e053-2a95a90ab0c92021-10-13WarningsExact identifier
spl id: ce391429-cedb-6616-e053-2995a90a1b17
spl set id: a96e7100-4ba9-1e45-e053-2a95a90ab0c9

Reported adverse events (FAERS/openFDA)#

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