FDA.reportPublic FDA data

SAITENM Health Wet wipes

Manufacturer
Shandong Saite New Material Co., Ltd.
Effective date
2020-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:06

Label at a glance#

ProductSAITENM Health Wet wipes
Active ingredientBENZALKONIUM, CHLORHEXIDINE GLUCONATE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Keep away from light, airtight, and store in a cool and dry place.

INACTIVE INGREDIENT SECTION

Glycerin, dodecyl pyridine chloride, Polysorbate-20, chitosan quaternary ammonium salt, water, chlorhexidine gluconate, propylene glycol, silylated polydimethylsiloxane, octanol, phenoxyethanol.

INDICATIONS & USAGE SECTION

1. Open the cover, uncover the sticker, and use it at will.
2. After use, please restore the original seal and close the cover.

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium,chlorhexidine gluconate

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

OTC - PURPOSE SECTION

Disinfection
Sterilization
No Rinseing

WARNINGS SECTION

1. This product is for extemal use, avoid entering the mouth, and put it out of reach of children.
2. Follow the "one object, one wipe" principle to avoid cross contamination.
3. Keep away from light, airtight, and store in a cool and dry place.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
92389-001-012022-01-28C16284748780-1d6a99b39-93a8-a426-e053-dadaa90af4c2aca57638-4bb7-a496-e053-2995a90a9d80

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
92389-001-01SAITENM Health Wet wipes80 in 1 BAGCLOTH801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
92389-001SAITENM HEALTH WET WIPES CLOTH [SHANDONG SAITE NEW MATERIAL CO., LTD.]1Legacy NDC, 1 package rows20200819_aca57638-4bb7-a496-e053-2995a90a9d80.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
92389-00192389-001-01

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
BENZALKONIUM7N6JUD5X6YACTIB
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
LAURYLPYRIDINIUM CHLORIDEKJM5A6A3YLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CAPRYLIC ALCOHOLNV1779205DIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
aca57638-4bb8-a496-e053-2995a90a9d80aca57638-4bb7-a496-e053-2995a90a9d802020-08-11WarningsExact identifier
spl id: aca57638-4bb8-a496-e053-2995a90a9d80
spl set id: aca57638-4bb7-a496-e053-2995a90a9d80

Reported adverse events (FAERS/openFDA)#

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