Label: HYGIENE HERO- super mist multi-purpose organic hand sanitizer liquid

  • 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 22, 2021

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    to help reduce bacteria on the skin

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    near eyes. In case of contact, rinse eyes thoroughly with water.

  • WHEN USING

    Do Not Usenear eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctorif skin irritation develops

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

  • STOP USE

    Stop use and ask a doctor if skin irritation develops

  • 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.

  • Directions

    Spray on palm, rub together until dry. Supervise children under 6.

  • Other information

    Do not store above 104°F (40°C)。Avoid placing under direct sun.

  • Inactive ingredients

    Water (Aqua), Bitter Orange (Citrus aurantium amara) peel oil*, Tea tree (Melaleuca Alternifolia) leaf oil*, May Chang (Litsea cubeba) fruit oil*, Limonene, Citral.

  • Package Label - Principal Display Panel

    100 mL NDC: 74139-444-01100 mL NDC: 74139-444-01

  • INGREDIENTS AND APPEARANCE
    HYGIENE HERO 
    super mist multi-purpose organic hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74139-444
    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
    TEA TREE OIL (UNII: VIF565UC2G)  
    LITSEA OIL (UNII: 2XIW34BN6O)  
    BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
    LEMON OIL, TERPENELESS (UNII: X69W83NI7V)  
    WATER (UNII: 059QF0KO0R)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74139-444-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/202003/30/2025
    Labeler - Berry White Inc (117447145)
    Registrant - Linea Bly SRL (441014352)
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