Label: BEAUTY NEW 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 April 23, 2020

If you are a consumer or patient please visit this version.

  • Uses

    antimicrobial

  • Directions

    Place enough Product in your palm to thorouhjly spread on both hands and rub into the skin until dre.

    Children under 6years of age should be supervised when using this product.

  • Warnings

    Flammable.Keep away from fire or flame.

    For external use only.

  • WHEN USING

    When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach for children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Other information

    • Store below 丨06°F.(41℃)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    WATER,GLYCERIN,PROPYLENE GLYCOL,

    HYDROXYETHYLCELLULOSE,

    HYDROGENATED CASTOR OIL

  • DOSAGE & ADMINISTRATION

    Store below 丨06°F.(41℃)

    May discolor certain fabrics or surfaces

  • KEEP OUT OF REACH OF CHILDREN

    Children under 6years of age should be supervised when using this product.

  • ACTIVE INGREDIENT

    2,3-DICHLORO-5,6-DICYANOBENZOQUINONE 0.15%

    POLYAMINOPROPYL BIGUANIDE 1%

    BENZALKONIUM CHLORIDE 0.15%

  • Label

    120503070300100500

  • INGREDIENTS AND APPEARANCE
    BEAUTY NEW HAND SANITIZER 
    beauty new hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75119-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.15 g  in 100 g
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) (POLYAMINOPROPYL BIGUANIDE - UNII:DT9D8Z79ET) POLYAMINOPROPYL BIGUANIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75119-002-0170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2020
    2NDC:75119-002-0230 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2020
    3NDC:75119-002-0350 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2020
    4NDC:75119-002-04500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2020
    5NDC:75119-002-05300 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2020
    6NDC:75119-002-06100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2020
    7NDC:75119-002-07120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/12/2020
    Labeler - SHANTOU LUNA NECESSARY CHEMICAL INDUSTRY CO.,LTD (528401180)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANTOU LUNA NECESSARY CHEMICAL INDUSTRY CO.,LTD528401180manufacture(75119-002) , label(75119-002)