Golden Medicated

Manufacturer
Kutol Products Company | Kutol Products Company, Inc.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:45:05

Label at a glance#

ProductGolden Medicated
Active ingredientCHLOROXYLENOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.3% w/w.......Antibacterial Handwashing

INACTIVE INGREDIENT SECTION

Water, Tall Oil Acid, Potassium Hydroxide, Sodium Lauryl Sulfate, Coconut Acid, Cocamide DIPA, Phenoxyethanol, Tetrasodium EDTA, Sodium Sulfate, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Iodopropynyl Butylcarbamate, Fragrance, Red 33, Yellow 5.

OTC - PURPOSE SECTION

Handwash to help decrease bacteria on the skin.

WARNINGS SECTION

For external use only.

Do not usein the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor ifirritation or rash appears and lasts.

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

DOSAGE & ADMINISTRATION SECTION

  • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
  • Children under 6 years of age should be supervised when using this product.

INDICATIONS & USAGE SECTION

Handwash to help decrease bacteria on the skin.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50865-060-09.jpg50865-060-09.jpg50865-060-09.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50865-060-27.jpg50865-060-27.jpg  50865-060-27.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN4
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD4
413261chloroxylenol 0.3 % Medicated Liquid SoapSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50865-060-092023-08-28C16284748780-1ba0f9c33-0e29-a910-e053-dadaa90a0b85Kutol F060
50865-060-272023-08-28C16284748780-1ba0f9c33-0e29-a910-e053-dadaa90a0b85Kutol F060
50865-060-092021-01-29C16284748780-1ba0f9c33-0e29-a910-e053-dadaa90a0b85Kutol F060
50865-060-272021-01-29C16284748780-1ba0f9c33-0e29-a910-e053-dadaa90a0b85Kutol F060

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-060-09Golden Medicated3785 mL in 1 BOTTLE, PLASTICSOLUTION37854
50865-060-27Golden Medicated1000 mL in 1 BAGSOLUTION10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-060GOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY]4Current NDC, Legacy NDC, 2 package rows20241220_e6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2Q1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2Q1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
COCO DIISOPROPANOLAMIDEINACTIVE INGREDIENTS485AM948Q1
COCONUT ACIDINACTIVE INGREDIENT40U37V505D1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP01
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21J1
TALL OIL ACIDINACTIVE INGREDIENTH9HR63474M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50865-06050865-060-09, 50865-060-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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 2 · 90 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+dosage form
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii+route
24 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii+route
18 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
18 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii+route
24 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JOINTMENT / TOPICAL14 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JLOTION / TOPICAL111 mgExact identifier — unii+route
24 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSOLUTION / DENTALNAExact identifier — unii+dosage form
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route
18 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii+route
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii+route
24 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii+route
24 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route
18 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii+route
24 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route
18 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route
18 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JLOTION / TOPICAL111 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0CREAM / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
18 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii+route
18 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SPRAY / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+dosage form
9 equally ranked IID candidates
COCONUT ACIDCOCONUT ACID40U37V505DSOLUTION / TOPICAL0.7 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SPRAY / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JSOAP / TOPICAL0.05 %w/wExact identifier — unii+route
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM SULFATESODIUM SULFATE0YPR65R21JSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
9 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0CREAM / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route
18 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii+route
24 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
9 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSOLUTION / ORAL2 mgExact identifier — unii+dosage form
9 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii+route
18 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JOINTMENT / TOPICAL14 mgExact identifier — unii+route
24 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
Golden MedicatedMEDICATED LOTION SOAPKutol Products Companye6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d2024-12-18WarningsExact identifier
ndc (package): 50865-060-09
ndc (package): 50865-060-27
ndc (product): 50865-060
ndc11 (package): 50865006027
ndc11 (package): 50865006009
spl id: 298f23a0-1c3b-6946-e063-6394a90aed9a
spl set id: e6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d

Reported adverse events (FAERS/openFDA)#

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