FDA.reportPublic FDA data

Optimize Thick Hand Sanitizer

Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | Keystone Industries
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:35

Label at a glance#

ProductOptimize Thick Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v.

OTC - PURPOSE SECTION

Purpose: Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, isopropyl myristate, carbomer, tocopheryl acetate, triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Keystone_HandSanitizer_Gal_4916648Keystone_HandSanitizer_Gal_4916648

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68400-486-012025-01-30C16284748780-12cef2736-b592-d83d-e063-dadaa90ab31fa35b4c73-d4b7-6a2a-e053-2a95a90adade

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-486-01Optimize Thick Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICGEL37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-486OPTIMIZE THICK HAND SANITIZER (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]2Current NDC, Legacy NDC, 1 package rows20220126_a35b4c73-d4b7-6a2a-e053-2a95a90adade.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68400-48668400-486-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Optimize Thick Hand SanitizerALCOHOLMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inca35b9348-c35f-7ba9-e053-2995a90a4a302024-12-11WarningsExact identifier
ndc (product): 68400-486
d66c045d-d1ec-2bd7-e053-2a95a90ae72ca35b4c73-d4b7-6a2a-e053-2a95a90adade2022-01-25WarningsExact identifier
spl id: d66c045d-d1ec-2bd7-e053-2a95a90ae72c
spl set id: a35b4c73-d4b7-6a2a-e053-2a95a90adade

Reported adverse events (FAERS/openFDA)#

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