APPLAUSE- instant hand sanitizer gel 
QuestSpecialty Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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QS Applause Drug Listing

Active Ingredient

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

purpose

Antiseptic

Uses

Warnings

do not use

When Using

Stop Use

Directions for Use

Water, triethanolamine, fragrance, acrylic polymer

label jpg

Applause QuartApplause Gallon8 oz bottle label55 gallon label5 gal pailbottle labelcarton label

APPLAUSE 
instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67858-693
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3 g  in 5 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67858-693-0224 in 1 CARTON10/02/2018
1NDC:67858-693-01107 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:67858-693-0412 in 1 CARTON10/02/2018
2NDC:67858-693-03212 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:67858-693-064 in 1 CARTON10/02/2018
3NDC:67858-693-053407 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:67858-693-07187358 g in 1 DRUM; Type 0: Not a Combination Product10/02/2018
5NDC:67858-693-0912 in 1 CARTON01/01/2021
5NDC:67858-693-08424 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/02/2018
Labeler - QuestSpecialty Corporation (103840377)
Registrant - QuestSpecialty Corporation (103840377)
Establishment
NameAddressID/FEIBusiness Operations
QuestSpecialty Corporation103840377manufacture(67858-693)

Revised: 3/2023
Document Id: f6e0703f-14d9-b1de-e053-6394a90aef1f
Set id: 774657f1-5c39-2fed-e053-2991aa0a9064
Version: 8
Effective Time: 20230314
 
QuestSpecialty Corporation