FDA Label for Zip Topical Anesthetic Gel Mint
View Indications, Usage & Precautions
Zip Topical Anesthetic Gel Mint Product Label
The following document was submitted to the FDA by the labeler of this product Germiphene Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Use Or Purpose:
For rapid topical anesthesia
Otc - Active Ingredient
Medicinal ingredient: Benzocaine 20.0% w/w
Otc - Purpose
Topical Anesthetic Gel
Inactive Ingredient
Non-Medicinal Ingredients: Propylene glycol, polyethylene glycol, carbomer, povidone, sodium saccharin, flavouring, and colouring agents. (Mint flavour only: ethyl alcohol, methyl paraben, propyl paraben).
Dosage & Administration
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.
Warnings
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.
Otc - Keep Out Of Reach Of Children
Caution: Keep out of reach of children.
Package Label.Principal Display Panel
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