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FDA Approval

Proctofoam

CompanyRebel Distributors Corp (DUNS: 118802834)

Effective Date

September 13, 2011

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocortisone acetate(100 mg in 10 g)

Hydrocortisone Acetate/Pramoxine Hydrochloride(100 mg in 10 g)

Manufacturing Establishments (1)

Rebel Distributors Corp

Labeler

Rebel Distributors Corp

DUNS Number

118802834

Products (1)

Proctofoam HC

NDC Product Code

21695-982

Application Number

ANDA086195

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

November 5, 2010

Ingredients

Hydrocortisone acetateActive

Code: 3X7931PO74Class: ACTIBQuantity: 100 mg in 10 g

cetyl alcoholInactive

Code: 936JST6JCNClass: IACT

trolamineInactive

Code: 9O3K93S3TKClass: IACT

methylparabenInactive

Code: A2I8C7HI9TClass: IACT

propylparabenInactive

Code: Z8IX2SC1OHClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

isobutaneInactive

Code: BXR49TP611Class: IACT

propaneInactive

Code: T75W9911L6Class: IACT

Hydrocortisone Acetate/Pramoxine HydrochlorideActive

Code: 88AYB867L5Class: ACTIBQuantity: 100 mg in 10 g

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