MedPath
FDA Product

Ocuvel

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

Basic Information

Ocuvel

69054-210

Regulatory Information

69054-210

November 7, 2014

Ocuvel CapsulesRx Only

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Adler-Stern Pharmaceuticals, LLC

079403232

Active Ingredients

Folic Acid

Quantity: 1 mg in 1 1

Code: 935E97BOY8

Class Code: ACTIB

ASCORBIC ACID

Quantity: 500 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

Zinc oxide

Quantity: 80 mg in 1 1

Code: SOI2LOH54Z

Class Code: ACTIB

Lutein

Quantity: 10 mg in 1 1

Code: X72A60C9MT

Class Code: ACTIB

Zeaxanthin

Quantity: 2 mg in 1 1

Code: CV0IB81ORO

Class Code: ACTIB

Gelatin

Code: 2G86QN327L

Class Code: IACT

Titanium Dioxide

Code: 15FIX9V2JP

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

ALPHA-TOCOPHEROL ACETATE

Quantity: 400 [iU] in 1 1

Code: 9E8X80D2L0

Class Code: ACTIB

Copper

Quantity: 2 mg in 1 1

Code: 789U1901C5

Class Code: ACTIB

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Active Moieties

ASCORBIC ACID

Code: PQ6CK8PD0R

.ALPHA.-TOCOPHEROL

Code: H4N855PNZ1

ZEAXANTHIN

Code: CV0IB81ORO

FOLIC ACID

Code: 935E97BOY8

ZINC OXIDE

Code: SOI2LOH54Z

copper

Code: 789U1901C5

LUTEIN

Code: X72A60C9MT

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