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PCXX ONE MINTE GEL CREME DE MENTHE

Approved
Approval ID

47d28652-9ec2-4ca9-b6c7-8007b3e0963b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 21, 2014

Manufacturers
FDA

Ross Healthcare Inc.

DUNS: 244249012

Products 1

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

FLUORIDE TREATMENT

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62007-006
Product Classification
G
Generic Name
FLUORIDE TREATMENT
Product Specifications
Route of Administrationtopical
Effective DateMay 29, 2014
FDA Product Classification

INGREDIENTS (2)

FD&C GREEN NO. 3Inactive
Quantity: .03 mg in 1 mg
Code: 3P3ONR6O1S
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 27.2 mg in 1 mg
Code: 8ZYQ1474W7
Classification: ACTIM

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PCXX ONE MINTE GEL CREME DE MENTHE - FDA Drug Approval Details