Procto-kit

Name: Procto-kit

Manufacturer

  • Ranbaxy Laboratories Ltd.

  • Ranbaxy Pharmaceuticals, Inc.

Procto-Kit Drug Class

Procto-Kit is part of the drug classes:

  • Corticosteroids acting locally

  • Corticosteroids for local oral treatment

  • Antiinflammatory Corticosteroids

  • Corticosteroids, weak group I

  • Corticosteroids, weak, other combinations

  • Corticosteroids/antiinfectives/mydriatics in combination

  • Glucocorticoids

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

How is Procto-kit Supplied

Proctosol-HC® 2.5% (Hydrocortisone Cream USP, 2.5%) in 1 oz (28.35 g) tubes

NDC 10631-407-01.

Store at 20º - 25º C (68º-77º F)

[see USP Controlled Room Temperature]. Protect from freezing.

Manufactured for:

Ranbaxy Laboratories, Inc.

Jacksonville, FL 32257 USA

Mfd By: Taro Pharmaceuticals Inc

Brampton, Ontario, Canada L6T 1C1

Revised: February 2014

Package label principal display panel

NDC 10631-407-01

RANBAXY LABORATORIES, INC.

Proctosol-HC® 2.5% (Hydrocortisone Cream USP, 2.5%)

Rx only

Net Wt 28.35 g (1 oz)

PROCTOSOL-HC 
hydrocortisone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10631-407
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 25 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
PROPYLENE GLYCOL MONOPALMITOSTEARATE  
MINERAL OIL  
LANOLIN OIL  
ISOPROPYL PALMITATE  
POLYSORBATE 60  
CETYL ALCOHOL  
SORBITAN MONOSTEARATE  
POLYOXYL 40 STEARATE  
SORBIC ACID  
METHYLPARABEN  
PROPYLPARABEN  
Packaging
# Item Code Package Description
1 NDC:10631-407-01 1 TUBE (TUBE) in 1 CARTON
1 28.35 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088799 04/28/2005
Labeler - Ranbaxy Laboratories Inc (169932519)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc 206263295 manufacture(10631-407)
Revised: 04/2014   Ranbaxy Laboratories Inc
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