Label: MAURICES I AM HAPPY HAND SANITIZER- hand sanitizer 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 July 16, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommend for repeated use
  • Warnings

    For external use only: hands
    Flammable, keep away from fire or flame.

    When using this product

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin
    • do not inhale or ingest

    Stop and ask a doctor if

    Stop and ask a doctor if

    • • irritation and redness develop
    • • condition persists for more than 72 hours

    Keep out of the reach of children

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

  • Directions

    • wet hands thoroughly with produc and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other Information

    • do not store above 105ºF
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive Ingredients

    Water/Aqua/Eau, Glycerin, PEG-7 Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Extract, Tocopheryl Acetate, Fragrance(Parfum), Limonene, Benzyl Salicylate, Geraniol, Linalool, Citronellol, Red 40 (CI 16035),
    Yellow 5 (CI 19140)

  • Package Label/Principal Display Panel

    NDC 79329-002-06; 60 ml

    Maurices I am Happy Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    MAURICES I AM HAPPY HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79329-002
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-7 OLEATE (UNII: 7W4ZYQ7UVQ)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GERANIOL (UNII: L837108USY)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79329-002-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    Labeler - Shanghai Sibei Cosmetic Co., Ltd. (542969967)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Sibei Cosmetic Co., Ltd542969967manufacture(79329-002)
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