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Stangard

Stangard Preventive Treatment Gel

Approved
Approval ID

7cae6a50-ee50-8827-e053-2991aa0a508f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2022

Manufacturers
FDA

Pascal Company, Inc.

DUNS: 009260217

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Topical SNF Fluoride Gel

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10866-0271
Product Classification
G
Generic Name
Topical SNF Fluoride Gel
Product Specifications
Route of AdministrationDENTAL
Effective DateDecember 19, 2022
FDA Product Classification

INGREDIENTS (2)

CARBOMER HOMOPOLYMER TYPE CInactive
Quantity: 12.56 mg in 1 g
Code: 4Q93RCW27E
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 3.8 mg in 1 g
Code: 3FTR44B32Q
Classification: ACTIM

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Stangard - FDA Drug Approval Details