Label: KLEEN HAND SANITIZER RELAXING LAVENDER- acohol gel

  • 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 20, 2020

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  • ACTIVE INGREDIENT

    Alcohol 70% v/v Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    Hand sanitizer to help decrease bacteria that can potentially cause disease. For use when soap and water are not available.

  • WARNINGS

    For external use only. Flammable. Keep away from heat and flame.

  • DO NOT USE

    Do not use

    • In children without aldult supervision
    • On open skin wound
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious conditions.

  • DOSAGE & ADMINISTRATION

    Directions:

    · Place enough product on hands to cover all surfaces. Rub hands together until dry.

    · Supervise children under 6 years of age when using this product to avoid swallowing.

  • STORAGE AND HANDLING

    Other information:

    • Store between 15-25oC (59-77oF)
    • Avoid freezing and excessive heat above 40oC (104oF)
  • INACTIVE INGREDIENT

    .Alpha.-terpinyl acetate, (+/-)-, .Beta.-pinene, .Beta.-caryophyllene oxide, 1-Octen-3-ol, 1-Octen-3-yl acetate, 3,5,5-Trimethylhexyl acetate, 3-Carene, 4-Terpineol, (+/-)-,4-Tert-butylcyclohexyl acetate, Benzoic acid, Butylated hydroxytoluene, Camphene, Camphor (synthetic), Carbomer interpolymer type a (allyl sucrose crosslinked), Caryophyllene, Coumarin, Dihydromyrcenol, Diphenyl ether, Eucalyptol, Geraniol, Geranyl acetate, Hexamethylindanopyran, Limonene, (+)-, Linalool, (+/-)-, Linalyl acetate, (+)-,Musk ketone, Nerol, Neryl acetate, P-cymene, Pinene, Polyoxyl 40 hydrogenated castor oil, Propylene glycol, Terpineol, Terpinolene, Trolamine, Water.

  • QUESTIONS

    +84-28-3742-1102

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • PRINCIPAL DISPLAY PANEL

    Kleen Hand Sanitizer Lavender 90mL LabelKleen Hand Sanitizer Lavender 100ml LabelKleen Hand Sanitizer Lavender 250 ml LabelKleen Hand Sanitizer Lavender 320ml LabelKleen Hand Sanitizer Lavender 500ml Label

  • INGREDIENTS AND APPEARANCE
    KLEEN HAND SANITIZER RELAXING LAVENDER 
    acohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79741-004
    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
    HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)  
    3-CARENE (UNII: H2M15SNR6N)  
    .BETA.-CARYOPHYLLENE OXIDE (UNII: S2XU9K448U)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHENE (UNII: G3VG94Z26E)  
    COUMARIN (UNII: A4VZ22K1WT)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DIPHENYL ETHER (UNII: 3O695R5M1U)  
    4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)  
    4-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 21EUM2B8UC)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    1-OCTEN-3-YL ACETATE (UNII: 2PZ32LCA02)  
    .BETA.-PINENE (UNII: 4MS8VHZ1HJ)  
    GERANYL ACETATE (UNII: 3W81YG7P9R)  
    TERPINOLENE (UNII: N9830X5KSL)  
    PINENE (UNII: 996299PUKB)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    LINALYL ACETATE, (+)- (UNII: 3ID3M89AV9)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    1-OCTEN-3-OL (UNII: WXB511GE38)  
    NEROL (UNII: 38G5P53250)  
    NERYL ACETATE (UNII: OF82IJU18H)  
    P-CYMENE (UNII: 1G1C8T1N7Q)  
    .ALPHA.-TERPINYL ACETATE, (+/-)- (UNII: 9RXE0I9F2J)  
    DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    3,5,5-TRIMETHYLHEXYL ACETATE (UNII: 9HMD71U17Z)  
    GERANIOL (UNII: L837108USY)  
    MUSK KETONE (UNII: 483V3E1L6J)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TERPINEOL (UNII: R53Q4ZWC99)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79741-004-0990 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2020
    2NDC:79741-004-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2020
    3NDC:79741-004-25250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2020
    4NDC:79741-004-32320 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2020
    5NDC:79741-004-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2020
    Labeler - SAIGON COSMETICS CORPORATION (555265180)
    Registrant - SAIGON COSMETICS CORPORATION (555265180)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAIGON COSMETICS CORPORATION555265180manufacture(79741-004)
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