Label: GINGICAINE GEL VARIETY PAK gel
- NDC Code(s): 10129-070-01
- Packager: Gingi-Pak a Division of the Belport
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 January 11, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Inactive Ingredients
- Warnings
- Precautions
- Consult a doctor promptly
- Allergy alert and contraindications
- Purpose
- Keep out of reach of children
- Dosage and Administration
- Indications and Uses
- Avoid excessive heat
- Gingicaine Gel Variety Pak Labels
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INGREDIENTS AND APPEARANCE
GINGICAINE GEL VARIETY PAK
gingicaine gel variety pak gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10129-070 Route of Administration DENTAL, ORAL, PERIODONTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 260 mg POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) 20 mg POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 520 mg Product Characteristics Color Score Shape Size Flavor CHERRY, STRAWBERRY, BANANA, PINEAPPLE (Pina Colada) , COTTON CANDY, CHOCOLATE (Chocolate Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10129-070-01 6 in 1 BOTTLE; Type 0: Not a Combination Product 06/09/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/09/2014 Labeler - Gingi-Pak a Division of the Belport (008480121)
