Label: ZIP TOPICAL ANESTHETIC GEL STRAWBERRY- benzocaine gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 61508-0202-1 - Packager: Germiphene Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated June 14, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE
- PURPOSE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
-
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, difficulty 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.
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZIP TOPICAL ANESTHETIC GEL STRAWBERRY
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61508-0202 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) 0.002 g in 100 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 43.7 g in 100 g POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 30.75 g in 100 g POVIDONE (UNII: FZ989GH94E) 0.25 g in 100 g SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.7 g in 100 g CARBOMER 934 (UNII: Z135WT9208) 3.1 g in 100 g Product Characteristics Color red Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61508-0202-1 30 g in 1 JAR; Type 0: Not a Combination Product 06/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/16/2017 Labeler - Germiphene Corporation (206412512) Establishment Name Address ID/FEI Business Operations Germiphene Corporation 206412512 manufacture(61508-0202)