NDC | 59428-500-42 |
Set ID | 1368d8bd-4263-4d8f-8a44-20571a8d6f8c |
Category | HUMAN OTC DRUG LABEL |
Packager | Productos Zapotol Corp. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions
- remove cap and cut tip of tube on score mark
- adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by doctor or dentist.
- children under 12 years of age should be supervised in the use of this product
- children under 2 years of age: ask a doctor/dentist
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZAPOTOL DENTIDOL ORAL ANALGESIC
benzocaine, and benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59428-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE .1 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59428-500-42 1 in 1 PACKAGE 11/01/2016 1 11.9 g in 1 CARTON; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/18/2015 Labeler - Productos Zapotol Corp. (186063850)