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PCXX ONE MINUTE COOL PEPPERMINT

Approved
Approval ID

5bcb9e45-82b4-47b6-804e-9b301df94849

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 3, 2015

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.

SODIUM FLUORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62007-054
Product Classification
G
Generic Name
SODIUM FLUORIDE
Product Specifications
Route of Administrationtopical
Effective DateFebruary 3, 2015
FDA Product Classification

INGREDIENTS (2)

FD&C BLUE NO. 1Inactive
Quantity: .001 mg in 1 mL
Code: H3R47K3TBD
Classification: IACT
SODIUM FLUORIDEActive
Quantity: .02 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM

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PCXX ONE MINUTE COOL PEPPERMINT - FDA Drug Approval Details