Label: RAGGEDY ANN AND ANDY FOAM- benzalkonium chloride soap

  • 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 December 6, 2010

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    • For hand washing and to decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    • For external use only.

    When using this product, keep out of eyes. In case of contact with eyes, immediately flush eyes with water. Avoid contact with broken skin.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Wet hands. Apply palm full to hands. Scrub thoroughly. Rinse. Recommended for repeated use.
  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, Glycerin, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate, FD&C Yellow No.5

  • PRINCIPAL DISPLAY PANEL - 221ml Bottle Label

    Raggedy
    Ann&Andy™

    ANTIBACTERIAL
    FORMULA Enriched
    with Vitamin E

    FOAM HAND SOAP

    Vanilla
    Bean

    7.5 FL OZ (221ml)

    Principal Display Panel - 221ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    RAGGEDY ANN AND ANDY FOAM   VANILLA BEAN
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75878-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.0013 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Glycerin (UNII: PDC6A3C0OX)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75878-003-75221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/20/2010
    Labeler - My Habitat Brands LLC (965398246)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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