Rectiv (Page 4 of 4)

Patient Instructions for Use

When do I apply the ointment?

Apply the ointment every 12 hours exactly as your doctor has told you to.

How do I apply the ointment?

Cover your finger with plastic-wrap, a disposable surgical glove or a finger cot.

Lay the covered finger alongside the 1 inch dosing line marked on the side of the medicine box (see figure below) so that the tip of your finger is at one end of the dosing line. Starting at the tip of the finger, squeeze the ointment onto your finger for the same length marked on the box.

Figure 2
(click image for full-size original)

Refer to carton for accurate dosage guide.

Gently insert the finger with the ointment into the anal canal, up to the first finger joint. Carefully smear the ointment around the inner sides of the anal canal. If this cannot be achieved due to pain, application of the ointment should be made directly to the outside of the anus.

What do I do after I have applied the ointment?

Throw away the finger covering in the garbage, out of the reach of children and pets. Wash your hands.

What are the ingredients in RECTIV?

Active ingredient: nitroglycerin

Inactive ingredients: propylene glycol, lanolin, sorbitan sesquioleate, paraffin wax and white petrolatum.

Manufactured by:
PHARBIL Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany

Distributed by:
Allergan USA, Inc.
Irvine, CA 92612
© 2017 Allergan. All rights reserved.
RECTIV® is a registered trademark of Aptalis Pharma US, Inc.
Allergan® and its design are trademarks of Allergan, Inc.

Revised: November 2016

73381US10

Principal Display Panel — Rectiv Carton Label

Allergan™

Use within 8 weeksof first opening.

30 g

RECTIV ®

(nitroglycerin)

Ointment 0.4%

For Intra-anal Use Only

Do not discard the carton – Dosage Guide included on two sides of the carton

Principal Display Panel -- Rectiv Carton Label
(click image for full-size original)

Principal Display Panel — Rectiv Tube Label

RECTIV ®

(nitroglycerin)

Ointment 0.4%

Principal Display Panel -- Rectiv Tube Label
(click image for full-size original)
RECTIV nitroglycerin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58914-301
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
LANOLIN
SORBITAN SESQUIOLEATE
PARAFFIN
WHITE PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58914-301-80 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (58914-301-80)
2 NDC:58914-301-85 1 TUBE in 1 CARTON contains a TUBE
2 5 g in 1 TUBE This package is contained within the CARTON (58914-301-85)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021359 06/21/2011
Labeler — Allergan, Inc. (144796497)

Revised: 11/2022 Allergan, Inc.

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