FDA.reportPublic FDA data

Medi-Hands

Manufacturer
Topmost Chemical & Paper Corporation | Betco corporation, Ltd. | Betco Corpo, Ltd.
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:14

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
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68978-708MEDI-HANDS (CHLOROXYLENOL) SOAP [TOPMOST CHEMICAL & PAPER CORPORATION]3Legacy NDC20241228_ab972f54-30a4-6ba8-e053-2a95a90a8f4d.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68978-70868978-708-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCO DIETHANOLAMIDE92005F972DIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZYL BENZOATEN863NB338GIACT
LAURIC DIETHANOLAMIDEI29I2VHG38IACT
LAURIC ISOPROPANOLAMIDE82DUX3RRVUIACT
D&C GREEN NO. 58J6RDU8L9XIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CHLOROXYLENOL0F32U78V2QACTIB
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYL ALCOHOLY4S76JWI15IACT
ETHYLENE OXIDEJJH7GNN18PIACT
ETHYL METHYLPHENYLGLYCIDATEUD51D5KR4AIACT
CHLOROACETIC ACID5GD84Y125GIACT
DIOXANEJ8A3S10O7SIACT
CALCIUM SILICATES4255P4G5MIACT
SODIUM FERROCYANIDE5HT6X21AIDIACT
DIMETHYL BENZYL CARBINYL ACETATE6Y9488RL8HIACT
GLYCOL DISTEARATE13W7MDN21WIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
MAGNESIUM NITRATE77CBG3UN78IACT
ETHYL BUTYRATEUFD2LZ005DIACT
MYRCENE3M39CZS25BIACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYL ANTHRANILATE981I0C1E5WIACT
SODIUM ALUMINIUM SILICATE058TS43PSMIACT
ETHYL ACETOACETATEIZP61H3TB1IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
SODIUM CARBONATE45P3261C7TIACT
.GAMMA.-DECALACTONE7HLS05KP9OIACT
LINALOOL, (+/-)-D81QY6I88EIACT
DIMETHYL BENZYL CARBINYL BUTYRATE3Q0C60547RIACT

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
41d4dc25-951d-0663-e063-6394a90ae576ab972f54-30a4-6ba8-e053-2a95a90a8f4d2025-10-23WarningsExact identifier
spl set id: ab972f54-30a4-6ba8-e053-2a95a90a8f4d

Reported adverse events (FAERS/openFDA)#

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