Label: GINGICAINE FUSION- benzocaine gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 10129-040-01, 10129-040-20, 10129-041-01, 10129-041-20 - Packager: Gingi-Pak a Division of the Belport
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 7, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Allergy Alert
- Consult a doctor
- Avoid Excessive heat
- Caution
- Contraindications
- Directions for Use
- Dosage & Administration
- Inactive Ingredients
- Indications
- Keep out of reach of children
- Overdosage
- Precautions
- Temper Evident Statement
- Uses
- Warnings
- Description
- Principal Display
-
INGREDIENTS AND APPEARANCE
GINGICAINE FUSION
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10129-041 Route of Administration TOPICAL, 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 POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 24 g in 100 g CANNABIDIOL (UNII: 19GBJ60SN5) 2 g in 100 g POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 52 g in 100 g POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) 2 g in 100 g Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10129-041-01 14 g in 1 JAR; Type 0: Not a Combination Product 06/04/2021 2 NDC:10129-041-20 20 in 1 BOX 06/04/2021 2 1.2 g in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/04/2021 GINGICAINE FUSION
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10129-040 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 Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 24 g in 100 g CANNABIDIOL (UNII: 19GBJ60SN5) 2 g in 100 g POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) 2 g in 100 g POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 52 g in 100 g Product Characteristics Color Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10129-040-01 14 g in 1 JAR; Type 0: Not a Combination Product 06/04/2021 2 NDC:10129-040-20 20 in 1 BOX 06/04/2021 2 1.2 g in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/04/2021 Labeler - Gingi-Pak a Division of the Belport (008480121) Registrant - Jeff Nichols (008480121) Establishment Name Address ID/FEI Business Operations Gingi-Pak a Division of the Belport 008480121 manufacture(10129-040, 10129-041)
