FDA.reportPublic FDA data

KUNDAL PURE and SAFE SANITIZING WIPE PLUS (BENZALKONIUM CHLORIDE)

Manufacturer
THESKINFACTORY Co., Ltd. | C&TECH CORPORATION
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:33:45

Label at a glance#

ProductKUNDAL PURE and SAFE SANITIZING WIPE PLUS (BENZALKONIUM CHLORIDE)
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

benzalkonium chloride

INACTIVE INGREDIENT SECTION

Water
Aloe Barbadensis Leaf Extract
Camellia Sinensis Leaf Extract
Chamomilla Recutita (Matricaria) Extract
Phenoxyethanol
Cetylpyridinium Chloride
Caprylyl Glycol
Cocamidopropyl PG-Dimonium Chloride Phosphate
Citric Acid

OTC - PURPOSE SECTION

hand sanitizing tissue to help reduce bacteria on the skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

pull ouy wipes and sanitize hands when necessary

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

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN3
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD3
1038856benzalkonium chloride 0.1 % Medicated WipesSY3
1038856benzalkonium chloride 0.1 % Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74773-0026-12022-01-28C16284748780-1d6a99b39-9817-a426-e053-dadaa90af4c2aee7780f-9f7e-0940-e053-2995a90a8db7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74773-0026-1KUNDAL PURE and SAFE SANITIZING WIPE PLUS (BENZALKONIUM CHLORIDE)7 g in 1 POUCHLIQUID73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74773-0026KUNDAL PURE AND SAFE SANITIZING WIPE PLUS (BENZALKONIUM CHLORIDE) (BENZALKONIUM CHLORIDE) LIQUID [THESKINFACTORY CO., LTD.]3Legacy NDC, 1 package rows20201117_aee7780f-9f7e-0940-e053-2995a90a8db7.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74773-002674773-0026-1

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
POLYSORBATE 207T1F30V5YHIACT
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MATRICARIA RECUTITAG0R4UBI2ZZIACT
SODIUM CITRATE1Q73Q2JULRIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM BENZOATEOJ245FE5EUIACT

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
b4370657-e007-7245-e053-2a95a90ada09aee7780f-9f7e-0940-e053-2995a90a8db72020-11-16WarningsExact identifier
spl id: b4370657-e007-7245-e053-2a95a90ada09
spl set id: aee7780f-9f7e-0940-e053-2995a90a8db7

Reported adverse events (FAERS/openFDA)#

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