Label: GINGICAINE GEL, PINA COLADA- gingicaine gel, pina colada flavor gel
- NDC Code(s): 10129-033-01, 10129-033-05
- 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 December 9, 2021
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- Active Ingredients
- Inactive Ingredients
- Precautions
- Warnings
- Consult a doctor promptly
- Allergy Alert and Contraindication
- Purpose
- Keep out of reach of children
- Dosage and Adminstration
- Indications and Use
- Avoid excessive heat
- GingiCaine Gel, Pina Colada label
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INGREDIENTS AND APPEARANCE
GINGICAINE GEL, PINA COLADA
gingicaine gel, pina colada flavor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10129-033 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 520 mg POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) 20 mg Product Characteristics Color orange (Pina Colada flavor) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10129-033-01 1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/06/1993 2 NDC:10129-033-05 6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/06/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/06/1993 Labeler - Gingi-Pak a Division of the Belport (008480121)
