Label: KELLYS DELIGHT HAND SANITIZER (APPLE CIDER)- alcohol gel

  • NDC Code(s): 79175-010-01, 79175-010-02, 79175-010-03, 79175-010-04, view more
    79175-010-05, 79175-010-06, 79175-010-07, 79175-010-08, 79175-010-09, 79175-010-10, 79175-010-11
  • Packager: WACO BOTTLING LLC
  • 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 August 3, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

    For use when soap and water are not available.

  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    •Wet hands.

    •Briskly rub hands together until dry.

    •Supervise children in the use of this product.

  • Other Information

    •Store at 20-25C(68-77F)

    •Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    Water, Fragrance (Parfum), Glycerin, lsopropyl Myristate, PEG-6 & AMP Acrylates I Vinyl lsodecanoate Crosspolymer, Tocopheryl Acetate.

  • Package Label - Principal Display Panel

    Kellys Delight Apple Cider Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    KELLYS DELIGHT HAND SANITIZER  (APPLE CIDER)
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79175-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)  
    METHYL CINNAMATE (UNII: 533CV2ZCQL)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    METHYL DIHYDROJASMONATE, (-)-TRANS- (UNII: XM1C2C5MMN)  
    .ALPHA.-ISOPROPYL-PHENETHYL ALCOHOL (UNII: N06AQ6J88Y)  
    DIETHYL MALONATE (UNII: 53A58PA183)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79175-010-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    2NDC:79175-010-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    3NDC:79175-010-03236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    4NDC:79175-010-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    5NDC:79175-010-05500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    6NDC:79175-010-06946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    7NDC:79175-010-071000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    8NDC:79175-010-081893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    9NDC:79175-010-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    10NDC:79175-010-1018927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    11NDC:79175-010-11208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2020
    Labeler - WACO BOTTLING LLC (080331158)
    Establishment
    NameAddressID/FEIBusiness Operations
    WACO BOTTLING LLC080331158manufacture(79175-010)
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