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

Drug Label Information

Updated December 8, 2024

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  • 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 Drug505G(a)(3)10/02/2018
    Labeler - QuestSpecialty Corporation (103840377)
    Registrant - QuestSpecialty Corporation (103840377)
    Establishment
    NameAddressID/FEIBusiness Operations
    QuestSpecialty Corporation103840377manufacture(67858-693)
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