FDA.reportPublic FDA data

Hand Essentials Instant Hand Antiseptic

Product NDC
65626-206
11-digit product format
656260206
Labeler code
65626
Product ID
65626-206_4833f63f-c875-19bf-e063-6394a90abcdc
Type
HUMAN OTC DRUG
Nonproprietary name
ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Hu-Friedy Mfg. Co., Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-10-01
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Essentials Instant Hand Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65626-206-04Hand Essentials Instant Hand Antiseptic118 mL in 1 BOTTLE, PUMPGEL11812
65626-206-06Hand Essentials Instant Hand Antiseptic473 mL in 1 BOTTLE, PUMPGEL47312
65626-206-12Hand Essentials Instant Hand Antiseptic44.4 mL in 1 BOTTLEGEL44.412

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MHAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
ALCOHOLACTIVE MOIETY3K9958V90MHAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NHAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208HAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302HAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKHAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65626-206HAND ESSENTIALS INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [HU-FRIEDY MFG. CO., INC.]10Current NDC, Legacy NDC, 3 package rows20241116_a580ebfb-2da9-4a20-9a3c-6244dbb7aef1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa580ebfb-2da9-4a20-9a3c-6244dbb7aef112
581662ethanol 0.7 ML/ML Topical GelSCDa580ebfb-2da9-4a20-9a3c-6244dbb7aef112
581662ethanol 70 % Topical GelSYa580ebfb-2da9-4a20-9a3c-6244dbb7aef112
581662ethyl alcohol 70 % Topical GelSYa580ebfb-2da9-4a20-9a3c-6244dbb7aef112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65626-206-0465626020604118 mL in 1 BOTTLE, PUMP (65626-206-04) 118 ml2010-10-010000-00-00NoNoCurrent
65626-206-0665626020606473 mL in 1 BOTTLE, PUMP (65626-206-06) 473 ml2010-10-010000-00-00NoNoCurrent
65626-206-126562602061244.4 mL in 1 BOTTLE (65626-206-12) 44.4 ml2010-10-010000-00-00NoNoCurrent