ZCAINE FAST ACTING ANESTHETIC- lidocaine gel

Zcaine Fast Acting Anesthetic by

Drug Labeling and Warnings

Zcaine Fast Acting Anesthetic by is a Otc medication manufactured, distributed, or labeled by PHI, Inc, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Zcaine Fast Acting Anesthetic Gel

Drug Facts

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

For the temporary relief of discomfort and pain associated with

• minor burns and skin irritations
• minor cuts and scrapes
• itching
  

Warnings:

For external use only.

Avoid contact with eyes.

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

Stop use and ask a doctor if

• skin becomes irritated
• condition worsens or symptoms last more than 7 days
• symptoms clear up and reoccur within a few days
  

Keep out of reach of children

Directions

Adults and children 12 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

Zcaine Fast Acting Anesthetic Gel 2oz/60g

INGREDIENTS AND APPEARANCE

ZCAINE FAST ACTING ANESTHETIC 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27789-911
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: 27789-911-02	60 g in 1 BOTTLE; Type 0: Not a Combination Product	04/04/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/04/2012

Labeler - PHI, Inc (611203035)

Registrant - Filltech USA, LLC (965596435)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(27789-911)