FDA.reportPublic FDA data

82877-001 Gout Ointment

Manufacturer
Shenzhen Boceda New Technology Co., Ltd.
Effective date
2022-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:17:43

Label at a glance#

ProductGout
Active ingredientCHLORHEXIDINE ACETATE
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Massage to absorb Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

[STORÁGE AND HANDLING SECTION]EDIT Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine Acetate 0.3%

Purpose

OTC - PURPOSE SECTION

Skin Antibacterial

Use

INDICATIONS & USAGE SECTION

Inhibitory effect on Staphylococcus aureus, Escherichia coli, Candida albicans For external use only.

Do not use

OTC - DO NOT USE SECTION

Pregnant women and those allergic to this product are prohibitedon open on open skin wounds

WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, 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. If swallowed, get medical help or contact a Poison Control Center right away

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contac a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Massage to absorb Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

[STORÁGE AND HANDLING SECTION]EDIT

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Cauliflower, Menthol, Myrrh

Warnings

WARNINGS SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82877-001-0182877-001-0182877-001-0282877-001-0282877-001-0382877-001-0382877-001-0482877-001-04

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
82877-001-012023-07-28C16284748780-10191ceaa-64bd-198a-e063-dbdaa90aec3e82877-001 Gout Ointment
82877-001-022023-07-28C16284748780-10191ceaa-64bd-198a-e063-dbdaa90aec3e82877-001 Gout Ointment
82877-001-032023-07-28C16284748780-10191ceaa-64bd-198a-e063-dbdaa90aec3e82877-001 Gout Ointment
82877-001-042023-07-28C16284748780-10191ceaa-64bd-198a-e063-dbdaa90aec3e82877-001 Gout Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82877-001-01Gout20 g in 1 BOXOINTMENT201
82877-001-02Gout30 g in 1 BOXOINTMENT301
82877-001-03Gout50 g in 1 BOXOINTMENT501
82877-001-04Gout100 g in 1 BOXOINTMENT1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82877-001GOUT (GOUT OINTMENT) OINTMENT [SHENZHEN BOCEDA NEW TECHNOLOGY CO., LTD.]1Legacy NDC, 4 package rows20220713_e32f72db-5ce7-36a7-e053-2a95a90abbfa.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82877-00182877-001-01, 82877-001-02, 82877-001-03, 82877-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORHEXIDINE ACETATE5908ZUF22YACTIB
WATER059QF0KO0RIACT
CAULIFLOWER138LUT2DWVIACT
MENTHOLL7T10EIP3AIACT
MYRRHJC71GJ1F3LIACT

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
e32f72db-5ce8-36a7-e053-2a95a90abbfae32f72db-5ce7-36a7-e053-2a95a90abbfa2022-07-06WarningsExact identifier
spl id: e32f72db-5ce8-36a7-e053-2a95a90abbfa
spl set id: e32f72db-5ce7-36a7-e053-2a95a90abbfa

Reported adverse events (FAERS/openFDA)#

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