Zcaine Fast Acting Anesthetic

Dosage form: gel
Ingredients: LIDOCAINE 4g in 100g
Labeler: PHI, Inc
NDC Code: 27789-911

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.

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

  • 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

ZCAINE FAST ACTING ANESTHETIC 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27789-911
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CALENDULA OFFICINALIS FLOWER 
GREEN TEA LEAF 
CHAMOMILE 
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
GLYCERIN 
MENTHOL 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
ALCOHOL 
COMFREY LEAF 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:27789-911-0260 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34804/04/2012
Labeler - PHI, Inc (611203035)
Registrant - Filltech USA, LLC (965596435)
Establishment
NameAddressID/FEIOperations
Filltech USA, LLC965596435manufacture

Revised: 04/2012
 
PHI, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)