FDA.reportPublic FDA data

Gentle Beast Antibacterial Wipes

Manufacturer
AJ Co., Ltd.
Effective date
2021-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:01

Label at a glance#

ProductGentle Beast Antibacterial Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride

INACTIVE INGREDIENT SECTION

water, propylene glycol, phenoxyethanol, glycerin, sodium benzoate, sodium citrate, disodium edta, polysorbate 20, citric acid, melaleuca alternifolia (tea tree) leaf oil, tocopheryl acetate

OTC - PURPOSE SECTION

Antibacterial Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

Thoroughly wipe hands with wipe.

Discard properly. Not flushable.

Be sure to close lid to keep wipes moist.

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

11labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75356-0007-12025-01-30C16284748780-12cef2736-929a-d83d-e063-dadaa90ab31fAJ Co., Ltd. - Gentle Beast Antibacterial Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75356-0007-1Gentle Beast Antibacterial Wipes337 g in 1 PACKETSWAB3372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75356-0007GENTLE BEAST ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) SWAB [AJ CO., LTD.]2Legacy NDC, 1 package rows20210317_bd28b3c5-13db-6f51-e053-2a95a90a63cf.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75356-000775356-0007-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TEA TREE OILVIF565UC2GIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CITRATE1Q73Q2JULRIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
bdb2dfed-8088-6c50-e053-2a95a90a637bbd28b3c5-13db-6f51-e053-2a95a90a63cf2021-03-16WarningsExact identifier
spl id: bdb2dfed-8088-6c50-e053-2a95a90a637b
spl set id: bd28b3c5-13db-6f51-e053-2a95a90a63cf

Reported adverse events (FAERS/openFDA)#

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