ZCAINE FAST ACTING ANESTHETIC- lidocaine gel 
PHI, Inc

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Zcaine Fast Acting Anesthetic Gel

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

Warnings:

For external use only.

Avoid contact with eyes.

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

Stop use and ask a doctor if



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

ZcaineTubeZcaineFrontPanel

ZCAINE FAST ACTING ANESTHETIC 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27789-911
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27789-911-0260 g in 1 BOTTLE; Type 0: Not a Combination Product04/04/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/04/2012
Labeler - PHI, Inc (611203035)
Registrant - Filltech USA, LLC (965596435)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(27789-911)

Revised: 11/2023
Document Id: 09c29a75-1487-1335-e063-6394a90a7f27
Set id: d072243f-6ba6-4ab6-8ebf-a2381fa9c2df
Version: 4
Effective Time: 20231109
 
PHI, Inc