SONACAINE TOPICAL ANESTHETIC WITH MENTHOL- lidocaine gel

Sonacaine Topical Anesthetic With Menthol by

Drug Labeling and Warnings

Sonacaine Topical Anesthetic With Menthol by is a Otc medication manufactured, distributed, or labeled by Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Sonacaine Topical Anesthetic Gel With Menthol

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

temporary relieves pain and itching due to:

• minor cuts
• sunburn
• minor scrapes
• minor burns
• insect bites
• minor skin irritations
  

Warnings:

For external use only.

Keep out of reach of children

Directions:

Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Other Ingredients:

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Sonacaine Topical Anesthetic Gel With Menthol 2oz/60g (

62221-935-02)

INGREDIENTS AND APPEARANCE

SONACAINE TOPICAL ANESTHETIC WITH MENTHOL 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62221-935
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
COMFREY LEAF (UNII: DG4F8T839X)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62221-935-02	60 g in 1 BOTTLE; Type 0: Not a Combination Product	05/02/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/02/2012

Labeler - Filltech USA, LLC (926433855)

Registrant - Filltech USA, LLC (926433855)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(62221-935)