FDA.reportPublic FDA data

Applause

Manufacturer
QuestSpecialty Corporation
Effective date
2024-12-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:41:15

Label at a glance#

ProductApplause
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Handwash to help decrease bacterial on the skin. Recommended for repeated use.

Dosage and administration

Place a palmful ( 5 grams) of product in one hand,. Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes). Place a smaller amolunt (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds). Will air dry in 15 seconds.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 60%..........Antiseptic

purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Handwash to help decrease bacterial on the skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

  • Flammable. Keep away from fire or flame.
  • For external use only.

do not use

OTC - DO NOT USE SECTION

  • In the eyes

When Using

OTC - WHEN USING SECTION

  • Do not use in or near the eyes.
  • If contact occurs, flush eyes with water for 15 minutes. Consult physician if irritatioin persists.
  • If swallowed, seek medical assitance or consult a poison control cener immediately.

Stop Use

OTC - STOP USE SECTION

  • Stop use and ask a doctor if: Irritation develops. If condtion persists for more than 72 hours consult a doctor.
  • Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

Directions for Use

DOSAGE & ADMINISTRATION SECTION

  • Place a palmful ( 5 grams) of product in one hand,.
  • Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).
  • Place a smaller amolunt (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds).
  • Will air dry in 15 seconds.

OTHER SAFETY INFORMATION

  • Store below 95 o F.
  • Close spout to avoid evaporation.

INACTIVE INGREDIENT SECTION

Water, triethanolamine, fragrance, acrylic polymer

label jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Applause QuartApplause QuartApplause GallonApplause Gallon8 oz bottle label8 oz bottle label55 gallon label55 gallon label5 gal pail5 gal pailbottle labelbottle labelcarton labelcarton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581658ethanol 60 % Topical GelPSN9
581658ethanol 0.6 ML/ML Topical GelSCD9
581658ethanol 60 % Topical GelSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67858-693-01Applause107 g in 1 BOTTLEGEL1079
67858-693-02Applause24 in 1 CARTONGEL249
67858-693-03Applause212 g in 1 BOTTLE, PLASTICGEL2129
67858-693-04Applause12 in 1 CARTONGEL129
67858-693-05Applause3407 g in 1 BOTTLE, PLASTICGEL34079
67858-693-06Applause4 in 1 CARTONGEL49
67858-693-07Applause187358 g in 1 DRUMGEL1873589
67858-693-08Applause424 g in 1 BOTTLE, PLASTICGEL4249
67858-693-09Applause12 in 1 CARTONGEL129

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67858-693APPLAUSE (INSTANT HAND SANITIZER) GEL [QUESTSPECIALTY CORPORATION]9Current NDC, Legacy NDC, 9 package rows20241209_774657f1-5c39-2fed-e053-2991aa0a9064.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67858-69367858-693-01, 67858-693-02, 67858-693-03, 67858-693-04, 67858-693-05, 67858-693-06, 67858-693-07, 67858-693-08, 67858-693-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
ApplauseINSTANT HAND SANITIZERQuestSpecialty Corporation774657f1-5c39-2fed-e053-2991aa0a90642024-12-08WarningsExact identifier
ndc (package): 67858-693-02
ndc (package): 67858-693-07
ndc (package): 67858-693-06
ndc (package): 67858-693-08
ndc (package): 67858-693-05
ndc (package): 67858-693-04
ndc (package): 67858-693-01
ndc (package): 67858-693-09
ndc (package): 67858-693-03
ndc (product): 67858-693
ndc11 (package): 67858069307
ndc11 (package): 67858069306
ndc11 (package): 67858069308
ndc11 (package): 67858069304
ndc11 (package): 67858069305
ndc11 (package): 67858069301
ndc11 (package): 67858069302
ndc11 (package): 67858069309
ndc11 (package): 67858069303
spl id: 28c533c1-0cf6-d184-e063-6294a90aeb64
spl set id: 774657f1-5c39-2fed-e053-2991aa0a9064

Reported adverse events (FAERS/openFDA)#

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