Label: KLEEN HAND SANITIZER MANGO- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 21, 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.

  • 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.

  • 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)
  • QUESTIONS

    +84-28-3742-1102

  • INACTIVE INGREDIENT

    .Alpha.-hexylcinnamaldehyde, .Gamma.-undecalactone, 1-(2,3,8,8-Tetramethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-Yl)ethanone, 2-(2-(4-Methylcyclohex-3-en-1-Yl)propyl)cyclopentan-1-one, 2-Tert-butylcyclohexyl acetate, 3-Hexenyl salicylate, cis-, 4-(P-hydroxyphenyl)-2-butanone, Bornyl acetate, (-)-, Carbomer interpolymer type A (allyl sucrose crosslinked), Diethyl malonate, Ethyl linalool, Ethyl maltol, Hexahydro-4,7-methanoinden-6-yl propionate, Hexyl acetate, Hexyl salicylate, Polyoxyl 40 hydrogenated castor oil, Propylene glycol, Trolamine, Water

  • PRINCIPAL DISPLAY PANEL

    Kleen Hand Sanitizer Mango Label 90mLKleen Hand Sanitizer Mango Label 100mLKleen Hand Sanitizer Mango 250 ml LabelKleen Hand Sanitizer Mango 320ml LabelKleen Hand Sanitizer Mango 500ml Label

  • INGREDIENTS AND APPEARANCE
    KLEEN HAND SANITIZER MANGO 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79741-003
    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
    DIETHYL MALONATE (UNII: 53A58PA183)  
    BORNYL ACETATE, (-)- (UNII: 24QAP1VCUX)  
    HEXYL ACETATE (UNII: 7U7KU3MWT0)  
    2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)  
    ETHYL LINALOOL (UNII: SF2JS9GF5T)  
    ETHYL MALTOL (UNII: L6Q8K29L05)  
    HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATE (UNII: S3ASM14UAS)  
    4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    2-(2-(4-METHYLCYCLOHEX-3-EN-1-YL)PROPYL)CYCLOPENTAN-1-ONE (UNII: P1K3Z8A8HJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
    WATER (UNII: 059QF0KO0R)  
    3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79741-003-0990 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2020
    2NDC:79741-003-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2020
    3NDC:79741-003-25250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2020
    4NDC:79741-003-32320 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/2020
    5NDC:79741-003-50500 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(79741-003)
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