ZIP TOPICAL ANESTHETIC GEL MINT- benzocaine gel 
Germiphene Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Zip Topical Anesthetic Gel Mint

Use or purpose:

For rapid topical anesthesia

Medicinal ingredient: Benzocaine 20.0% w/w

Topical Anesthetic Gel

Non-Medicinal Ingredients: Propylene glycol, polyethylene glycol, carbomer, povidone, sodium saccharin, flavouring, and colouring agents. (Mint flavour only: ethyl alcohol, methyl paraben, propyl paraben).

Directions: Apply approximately 0.2 mL of gel to the desired area using a cotton swab. For adults and children 2 years of age or older. For professional use only. Use only on the advice of a physician.

Warning: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water. Stop use and consult a health-care practitioner if the following symptoms appear: weakness, confusion, headache, dificulty breathing and/or pale, gray or blue coloured skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. Use smallest amount possible to achieve desired result. Do not use if allergic to benzocaine or any other ingredients in the product. Use with caution in children. Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight. Do not swallow.

Caution: Keep out of reach of children.

30 g

ZIP TOPICAL ANESTHETIC GEL MINT 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0201
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.565 g  in 100 g
POVIDONE (UNII: FZ989GH94E) 0.248 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) 0.065 g  in 100 g
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 0.0249 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00155 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.00016 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.00016 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.697 g  in 100 g
CARBOMER 934 (UNII: Z135WT9208) 3.086 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 43.29 g  in 100 g
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 30.62 g  in 100 g
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0201-130 g in 1 JAR; Type 0: Not a Combination Product06/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/16/2017
Labeler - Germiphene Corporation (206412512)
Establishment
NameAddressID/FEIBusiness Operations
Germiphene Corporation206412512manufacture(61508-0201)

Revised: 6/2017
Document Id: 51dccfdb-a9c9-1d4f-e054-00144ff8d46c
Set id: 51dccfdb-a9c8-1d4f-e054-00144ff8d46c
Version: 1
Effective Time: 20170613
 
Germiphene Corporation