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Zip Topical Anesthetic Gel Mint

Dosage form: gel
Ingredients: BENZOCAINE 20g in 100g
Labeler: Germiphene Corporation
NDC Code: 61508-0201

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.

ZIP TOPICAL ANESTHETIC GEL MINT 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0201
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER0.565 g  in 100 g
POVIDONE0.248 g  in 100 g
ALCOHOL0.065 g  in 100 g
D&C YELLOW NO. 100.0249 g  in 100 g
FD&C BLUE NO. 10.00155 g  in 100 g
METHYLPARABEN0.00016 g  in 100 g
PROPYLPARABEN0.00016 g  in 100 g
SACCHARIN SODIUM0.697 g  in 100 g
CARBOMER 9343.086 g  in 100 g
PROPYLENE GLYCOL43.29 g  in 100 g
POLYETHYLENE GLYCOL 40030.62 g  in 100 g
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:61508-0201-130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/16/2017
Labeler - Germiphene Corporation (206412512)
Establishment
NameAddressID/FEIOperations
Germiphene Corporation206412512manufacture(61508-0201)

Revised: 06/2017
 
Germiphene Corporation

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.

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