HUSH ANESTHETIC- lidocaine, benzalkonium chloride soap 
HUSH Anesthetic

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.

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HUSH Foam Soap

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

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

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

Label

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)

Revised: 1/2022
Document Id: 339f1eaf-18d6-4c6f-b48d-420e092f7ee3
Set id: e4cbc1a1-e3b3-4fd5-a019-df05e13a9aea
Version: 4
Effective Time: 20220114
 
HUSH Anesthetic