VANILLA SUGAR HAND SANITIZER (ALCOHOL) LIQUID [ENCHANTE ACCESSORIES INC. ]

VANILLA SUGAR HAND SANITIZER (ALCOHOL) LIQUID [ENCHANTE ACCESSORIES INC. ]
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NDC 50563-177-01
Set ID 2da5d907-4ca2-4fc9-9b96-e6149d7db642
Category HUMAN OTC DRUG LABEL
Packager ENCHANTE ACCESSORIES INC.
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    To decrease bacteria on the skin that could cause disease

    Recommended for repeated use

  • WARNINGS

    For external use only-hands

    Flammable. Keep away from heat and flame

    Keep out of eyes. In case of comtact with eyes, flush thoroughly with water

    Avoid contact with broken skin

  • ASK DOCTOR

    Do not inhale or ingest. Stop use and ask a doctor if skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product and allow to dry without wiping
    • For children under 6, use only under adult supervision
    • Not recommended for infants
  • SPL UNCLASSIFIED SECTION

    Other Information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    VANILLA SUGAR HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-177-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/02/2014
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(50563-177)

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