ROYAL NON-ALCOHOL FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [CWGC LA INC.]

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ROYAL NON-ALCOHOL FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [CWGC LA INC.]
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NDC 70415-205-01
Set ID 05364f49-c8a9-41a3-a536-9cc2f53bb884
Category HUMAN OTC DRUG LABEL
Packager CWGC LA Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active ingredient

    BENZALKONIUM CHLORIDE  0.13%

    Purpose

    Antibacterial

  • Uses

    • For handwashing to reduce bacteria on the skin. Recommended for repeated use.
  • Warnings

    For external use only

    Avoid contact with eyes. In case of eye contact, flush eyes with water.

    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 irritation or redness develops and persists.

  • Directions

    • Apply foam sanitizer to hands.
    • Rub over surfaces of both hands for 15 seconds.
    • No rinsing required.
  • Inactive ingredients

    Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Royal Product_Labels_Non-Alc Foam Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    ROYAL NON-ALCOHOL FOAM HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70415-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70415-205-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/22/2017
    Labeler - CWGC LA Inc. (034967904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Gotdya Fine Chemical Co., Ltd.551470189manufacture(70415-205)
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