Label: APPLAUSE- instant hand sanitizer gel

  • NDC Code(s): 67858-693-01, 67858-693-02, 67858-693-03, 67858-693-04, view more
    67858-693-05, 67858-693-06, 67858-693-07, 67858-693-08, 67858-693-09
  • Packager: QuestSpecialty Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 14, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

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

  • purpose

    Antiseptic

  • Uses

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

    • Flammable. Keep away from fire or flame.
    • For external use only.
  • do not use

    • In the eyes
  • When Using

    • 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

    • 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.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • Directions for Use

    • 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

    Water, triethanolamine, fragrance, acrylic polymer

  • label jpg

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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!