Label: ECO HARBOR HAND SANITIZING MIST EUCALYPTUS MINT- ethyl alcohol spray

  • NDC Code(s): 50563-471-01
  • Packager: ENCHANTE ACCESSORIES INC.
  • 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 June 2, 2023

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  • Active Ingredient

    Ethyl Alcohol: 75% (W/W)

  • Purpose

    Antiseptic

  • Use

    ■ To decrease bacteria on the skin that could cause disease
    ■Recommended for repeated use

  • WARNINGS

    For external use only

    Flammable. Keep away from heat and flame

    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 use and ask a doctor if skin irritation develops

    Keep out of reach of children.

    For children under 6 years of age, use only under adult supervision

    If swallowed, get medical help or contact a poison control center right away

  • Directions

    Spray into palm and rub hands together

    Allow to dry without wiping

  • Other information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Fragrance, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Mentha Arvensis Extract, Yellow 5, Blue 1.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ECO HARBOR HAND SANITIZING MIST EUCALYPTUS MINT 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-471
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-471-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2023
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Wally Bath Manufacture Co., Ltd548232606manufacture(50563-471)
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