Procto-Pak (Page 2 of 2)

HOW SUPPLIED

Hydrocortisone Cream USP 1%
1 oz (28.4 g) tube
Hydrocortisone Ointment USP 1%
1 oz (28.4 g) tube

Manufactured by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA

FORM NO. 0321/1326 Rev.10/14
VC4497

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64980-302-30

Rising

Procto-PackTM 1%

Hydrocortisone Cream USP, 1%

NOTE PHARMACIST:

See Patient Instructions on reverse side.

Store at room temperature. Avoid Freezing.

Rx Only

Rising Pharmaceuticals, Inc.
Allendale, NJ 07401

cream
(click image for full-size original)
PROCTO-PAK
hydrocortisone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-302
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
STEARYL ALCOHOL
GLYCERYL MONOSTEARATE
POLYOXYL 40 STEARATE
ISOPROPYL PALMITATE
PARAFFIN
SORBITAN MONOSTEARATE
GLYCERIN
LACTIC ACID
POTASSIUM SORBATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-302-30 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (64980-302-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087795 06/01/2012
Labeler — Rising Pharmaceuticals, Inc. (041241766)
Registrant — G&W NC Laboratories, LLC (079419931)
Establishment
Name Address ID/FEI Operations
G&W NC Laboratories, LLC 079419931 MANUFACTURE (64980-302)
Establishment
Name Address ID/FEI Operations
Nutra-Med Packaging, Inc. 080274725 REPACK (64980-302)

Revised: 12/2017 Rising Pharmaceuticals, Inc.

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