Hand Cleanse - Ocean Fresh

Manufacturer
China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2022-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:39

Label at a glance#

ProductHand Cleanse - Ocean Fresh
Active ingredientTRICLOSAN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

OTC - PURPOSE SECTION

Uses

forthe temporary relief of minor aches and pains of muscles and joints.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

INDICATIONS & USAGE SECTION

Other information

  • store at 20oC to 25oC (68o to 77oF)

WARNINGS SECTION

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with 

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product do not

  • heat
  • microwafe
  • add to hot water or any container where healing water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Consult a doctor and discontinue use if condition worsesn, persists for more than 1 week or tends to recur.

DOSAGE & ADMINISTRATION SECTION

Directions

  • see important warnings under "When using this product"
  • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: consult a physician.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabel imagelabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-010-012025-01-30C16284748780-12cef2736-aba9-d83d-e063-dadaa90ab31fHand Cleanse - Ocean Fresh

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-010-01Hand Cleanse - Ocean Fresh500 mg in 1 BOTTLEGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-010HAND CLEANSE - OCEAN FRESH (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3Legacy NDC, 1 package rows20221118_b09ecdf8-364f-48b7-811b-812f26e6ed01.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58503-01058503-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
edb1695d-1c93-157f-e053-2a95a90a020eb09ecdf8-364f-48b7-811b-812f26e6ed012022-11-17WarningsExact identifier
spl id: edb1695d-1c93-157f-e053-2a95a90a020e
spl set id: b09ecdf8-364f-48b7-811b-812f26e6ed01

Reported adverse events (FAERS/openFDA)#

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