HUSH ANESTHETIC- lidocaine, benzalkonium chloride soap

Hush Anesthetic by

Drug Labeling and Warnings

Hush Anesthetic by is a Otc medication manufactured, distributed, or labeled by HUSH Anesthetic. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HUSH ANESTHETIC 
lidocaine, benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49947-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49947-003-01	48.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2014

Labeler - HUSH Anesthetic (012011309)