FDA.reportPublic FDA data

Serdaen

Manufacturer
Browne Hansen LLC
Effective date
2013-06-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:35:42

Label at a glance#

ProductSerdaen
Active ingredientCHLORHEXIDINE ACETATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Chlorhexidine Diacetate 1%

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Cola Det SDC, Sodium Xylem Sulfate, Tocopheryl Acetate, Fragrance

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses

Prevent overgrowth of bacteria prior to surgical procedure

Prevent recurrent bacterial infections

Prevent infections around superficial wounds

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.

WARNINGS SECTION

Warnings

For external use only.

Do not use:

If allergic to Chlorhexidine or other ingredients in formulation

In contact with the genital area

On wounds that exceed the superficial layer of skin.

OTC - WHEN USING SECTION

When using this product

Avoid eye contact. Should contact occur,

rinse thoroughly with water.

OTC - STOP USE SECTION

Discontinue use and consult a health care practitioner

if irritation or allergic reaction develops.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply liberally to moistened area, wash and rinse thoroughly.

All product should be rinsed and dried immediately

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56149-002-022019-11-27C16284748780-19855d018-d28c-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56149-002-02Serdaen3 g in 1 BOXSOAP32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56149-002SERDAEN (CHLORHEXIDINE DIACETATE) SOAP [BROWNE HANSEN LLC]2Legacy NDC, 1 package rows20130614_e34e6caa-3360-4549-8a84-d8adcab1b3bb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE ACETATEACTIVE INGREDIENT5908ZUF22Y2
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C402
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PT2
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21J2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
56149-00256149-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORHEXIDINE ACETATE5908ZUF22YACTIB
WATER059QF0KO0RIACT
SODIUM SULFATE0YPR65R21JIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIPROPYLENE GLYCOLE107L85C40IACT
MONOETHANOLAMINE5KV86114PTIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM SULFATESODIUM SULFATE0YPR65R21JSOAP / TOPICAL0.05 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JTABLET, DELAYED RELEASE / ORAL16.24 mgExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JTABLET / ORAL182 mgExact identifier — unii candidate
7 equally ranked IID candidates
MONOETHANOLAMINE2-AMINOETHANOL5KV86114PTTABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JTABLET, COATED / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JSOLUTION/ DROPS / OPHTHALMIC13 mgExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JSOLUTION / OPHTHALMIC0.14 %w/vExact identifier — unii candidate
7 equally ranked IID candidates

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
cb80b579-2303-4261-8eba-426e54b7ffc7e34e6caa-3360-4549-8a84-d8adcab1b3bb2013-06-13WarningsExact identifier
spl id: cb80b579-2303-4261-8eba-426e54b7ffc7
spl set id: e34e6caa-3360-4549-8a84-d8adcab1b3bb

Reported adverse events (FAERS/openFDA)#

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