Hand Cleanse

Product NDC
58503-008
11-digit product format
585030008
Labeler code
58503
Product ID
58503-008_edb1695d-1c92-157f-e053-2a95a90a020e
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
GEL
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-05-24
Marketing end
0000-00-00
Substance
TRICLOSAN
Active strength
8 mg/500mg
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-008-012025-01-30C16284748780-12cef2736-82bc-d83d-e063-dadaa90ab31fHand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-008-01Hand CleanseRefill500 mg in 1 BOTTLEGEL5004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
TRICLOSANACTIVE MOIETY4NM5039Y5XHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RHAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-008HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]4Legacy NDC, 1 package rows20221118_2818fc19-d7c8-4253-80d5-c61a277b1a12.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-008-0158503000801500 mg in 1 BOTTLE (58503-008-01) 500 mg2013-05-240000-00-00NoNoCurrent