FDA Product

Phocal Apf

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Phocal Apf

FDA Product Code

55918-001

Regulatory Information

NDC Product Code

55918-001

Effective Date

February 12, 2013

FDA Title

phocal™

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

Manufacturer

U.S.I.A. Inc

DUNS Number

078525286

Active Ingredients

Sodium Fluoride

Quantity: 0.0466 mg in 1 1

Code: 8ZYQ1474W7

Class Code: ACTIM

HYDROFLUORIC ACID

Quantity: 0.0094 mg in 1 1

Code: RGL5YE86CZ

Class Code: ACTIM

FD&C Red No. 3

Code: PN2ZH5LOQY

Class Code: IACT

ACACIA

Code: 5C5403N26O

Class Code: IACT

gelatin

Code: 2G86QN327L

Class Code: IACT

PROPOLIS WAX

Code: 6Y8XYV2NOF

Class Code: IACT

phosphoric acid

Code: E4GA8884NN

Class Code: IACT

sodium benzoate

Code: OJ245FE5EU

Class Code: IACT

water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

FLUORIDE ION

Code: Q80VPU408O

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