Label: ANGEL OF MINE FOAMING HAND SANITIZER- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 15, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    to decrease bacteria on the skin

  • Warnings

    For external use only, hands only

  • When using this product

    ■ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water ■ avoid contact with broken skin

  • Stop use and ask a doctor if

    ■ irritation or redness develops ■ condition persists for more than 72 hours

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ wet hands thoroughly with product and allow to dry without wiping ■ for children under 6, use only under adult supervision

  • Inactive ingredients

    water, cetrimonium chloride, disodium cocoamphodiacetate, PEG-12 dimethicone, citrus reticulata X C sinensis peel extract, tocopheryl acetate, methylchloroisithiazolinone, methylisothiazolinone

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    ANGEL OF MINE  FOAMING HAND SANITIZER
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1450
    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
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    WATER (UNII: 059QF0KO0R)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    TANGERINE PEEL (UNII: JU3D414057)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1450-8236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - Greenbrier International, Inc (610322518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil533151022manufacture(33992-1450)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!