FDA.reportPublic FDA data

CALA ADVANCED HAND SANITIZING TISSUES

Manufacturer
Shin's Trading Co., Inc. Dba Cala Products
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:29:35

Label at a glance#

ProductCALA ADVANCED HAND SANITIZING TISSUES
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

Antimicrobial

Use[s]

INDICATIONS & USAGE SECTION

■ to reduce germs 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 or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. ■ These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions ■ Wet hands thoroughly with product and allow dry. ■ Reseal tissues after each use to avoid product from drying. ■ Supervise children under 6 years of age when using this product.

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, Glycerin, Hydroxyacetophenone, Cetylpyridinium Chloride, Citric Acid Monohydrate, Butylene Glycol, Aloe Ferox Leaf Extract

Questions or Comments?

OTC - QUESTIONS SECTION

1-231-745-5141

SPL UNCLASSIFIED SECTION

SANITIZING & REFRESHING

CLEAN HANDS

WITH ALOE VERA EXTRACT

Pre-moistened Santizing Tissues

5.9 x 7.9 in (15 x 20 cm)

MADE IN KOREA

Cleansing & Refreshing

ADVANCED HAND SANITIZING TISSUES

CAUTIONS: FOR EXTERNAL USE ONLY. If any product gets into eyes it may cause irritation, rinse eyes thoroughly with warm water. KEEP OUT OF REACH OF CHILDREN.

CALA® PRODUCTS

LOS ANGELES, CA 90007 U.S.A.

www.calaproduct.com

MADE IN SOUTH KOREA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN3
1489307ethanol 0.7 ML/ML Medicated PadSCD3
1489307ethanol 70 % Medicated PadSY3
1489307ethanol 70 % Medicated WipesSY3
1489307ethyl alcohol 70 % ClothSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74985-678-552022-01-28C16284748780-1d6a99b39-9508-a426-e053-dadaa90af4c2CALA ® ​Advanced HAND SANITIZING TISSUES
74985-678-562022-01-28C16284748780-1d6a99b39-9508-a426-e053-dadaa90af4c2CALA ® ​Advanced HAND SANITIZING TISSUES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74985-678-55CALA ADVANCED HAND SANITIZING TISSUES30 in 1 POUCHSWAB303
74985-678-55CALA ADVANCED HAND SANITIZING TISSUES4.19 mL in 1 PACKETSWAB4.193
74985-678-56CALA ADVANCED HAND SANITIZING TISSUES60 in 1 POUCHSWAB603
74985-678-56CALA ADVANCED HAND SANITIZING TISSUES4.65 mL in 1 PACKETSWAB4.653

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74985-678CALA ADVANCED HAND SANITIZING TISSUES (ALCOHOL) SWAB [SHIN'S TRADING CO., INC. DBA CALA PRODUCTS]3Legacy NDC, 4 package rows20200917_c7deac82-6cd3-417f-96d8-39b4c1752e4f.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
74985-67874985-678-55, 74985-678-56

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALOE FEROX LEAF0D145J8EMEIACT

Source Document#

Source XML · Source PDF

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
fc40262d-9760-41f0-9920-a8eb194ad948c7deac82-6cd3-417f-96d8-39b4c1752e4f2020-09-16WarningsExact identifier
spl id: fc40262d-9760-41f0-9920-a8eb194ad948
spl set id: c7deac82-6cd3-417f-96d8-39b4c1752e4f

Reported adverse events (FAERS/openFDA)#

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