Label: BODY PRESCRIPTIONS EUCALYPTUS ANTIBACTERIAL HAND SANITIZER- ethyl alcohol spray

  • 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 March 26, 2021

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  • Active Ingredient

    Alcohol Denat: 75%

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

  • 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

  • Other information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water, Fragrance, Blue 1, Yellow 5

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS EUCALYPTUS ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-418
    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
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-418-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/25/2021
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-418)
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