FDA.reportPublic FDA data

Medi-Hands

Manufacturer
Topmost Chemical & Paper Corporation | Betco corporation, Ltd. | Betco Corpo, Ltd.
Effective date
2019-05-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:24

Label at a glance#

ProductMedi-Hands
Active ingredientCHLOROXYLENOL
Label structure8 sections

Label contents#

Full prescribing information#

Medi-Hands

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredient

Chloroxylenol 0.375%

Medi-Hands

INDICATIONS & USAGE SECTION

Uses

  • ​​Antibacterial hand cleaner.
  • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Medi-Hands

WARNINGS SECTION

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • Children under the age of 6 should be supervised by an adult when using this product.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.

Medi-Hands

DOSAGE & ADMINISTRATION SECTION

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 1-2 pumps of product onto wet palm.
  • Lather and rinse hands with clean water

Medi-Hands

INACTIVE INGREDIENT SECTION

Inactive Ingredients

​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

Medi-Hands

OTC - PURPOSE SECTION

Purpose

Antibacterial

Medi-Hands

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Medi-Hands

KEEP OUT OF REACH OF CHILDREN

Medi-Hands Pearlized Antibacterial Skin Cleanser with PCMX Distributed by: TOPMOST CHEMICAL & PAPER CORP. 3394 Winchester Rd. Memphis, TN 38118 (901) 363-7278

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

14104-00_Topmost_MediHands

14104 Topmost MediHands14104 Topmost MediHands

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68978-141MEDI-HANDS (CHLOROXYLENOL) SOAP [TOPMOST CHEMICAL & PAPER CORPORATION]3Legacy NDC20190503_02096e3c-df6f-4ec2-99d7-3bc4f4b3e5c9.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68978-14168978-141-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCO DIETHANOLAMIDE92005F972DIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCOL STEARATE0324G66D0EIACT
LAURIC DIETHANOLAMIDEI29I2VHG38IACT
GLYCERINPDC6A3C0OXIACT
D&C GREEN NO. 58J6RDU8L9XIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CHLOROXYLENOL0F32U78V2QACTIB

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
41d4e2b9-f6d0-099d-e063-6394a90a829502096e3c-df6f-4ec2-99d7-3bc4f4b3e5c92025-10-23WarningsExact identifier
spl set id: 02096e3c-df6f-4ec2-99d7-3bc4f4b3e5c9

Reported adverse events (FAERS/openFDA)#

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