Label: HUSH ANESTHETIC- lidocaine, 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 January 14, 2022

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

View All Sections
  • Active Ingredients    

    Lidocaine 4% w/w

    Benzalkonium Chloride (0.13%) w/w

  • Purpose

    Pain Relieving Liquid

    First Aid Antiseptic

  • Uses

    First aid to help prevent bacterial contamination or skin infection and for temporary relief of pain and itching associated with minor cuts or minor skin irritations.

  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age, consult a physician.

  • Warnings

    For external use only • Avoid contact with the eyes

  • KEEP OUT OF REACH OF CHILDREN

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

  • DO NOT USE

    Do not use in large quantities, particularly over raw surfaces or blistered areas

  • STOP USE

    In case of deep or puncture wounds, animal bites, or serious bites, consult a doctor • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Calendula Officials Flower Extract, Caprylyl Glycol, Chamomile (Chamomilla Recutita) Flower Extract, Citric Acid, Cocamidopropyl Betaine, Comfrey (Symphytum Officinale) Root Extract, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Green Tea (Camellia Sinensis) Leaf Extract, Methylisothiazollnone, PEG-80 Sorbitan Laurate, Propylene Glycol

  • Other Information

    Questions or Comments? Call 305-231-7229 or visit www.hushanesthetic.com

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    HUSH ANESTHETIC 
    lidocaine, benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49947-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49947-003-0148.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2014
    Labeler - HUSH Anesthetic (012011309)
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!