Ivermectin (Page 3 of 3)

INSTRUCTION FOR USE

Ivermectin (eye” ver mek’ tin) Cream, 1%

Important: Ivermectin cream is for use on the face only. Do not use ivermectin cream in your eyes, mouth or vagina.

Read and follow the steps below so that you use ivermectin cream correctly:

1. Open the tube of ivermectin cream by gently pressing down on the child resistant cap and twist in the direction of the arrow (counterclockwise) as shown below. See Figures A and B. To avoid spilling, do not squeeze the tube while opening or closing.

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Figure A

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Figure B

2. To apply ivermectin cream to your face, squeeze a pea-sized amount of ivermectin cream from the tube onto your fingertip. See Figure C.

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Figure C

3. Apply ivermectin to the affected areas of your face once a day. Use a pea-sized amount of ivermectin cream for each area of your face (forehead, chin, nose, each cheek) that is affected. Spread the cream smoothly and evenly in a thin layer. Avoid contact with your eyes and lips.

4. To close ivermectin cream, gently press down on the child resistant cap and twist to the right (clockwise). See Figure D.

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Figure D

How should I store ivermectin cream?

  • Store ivermectin cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep ivermectin cream out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.


Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Revised – January 2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0591-4052-89
Ivermectin Cream 1%

45 GRAMS

TEVA

FOR TOPICAL USE ONLY

Not for Oral, Ophthalmic, or Intravaginal Use

Rx only

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(click image for full-size original)
IVERMECTIN
ivermectin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-4052
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IVERMECTIN (IVERMECTIN) IVERMECTIN 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
ANHYDROUS CITRIC ACID
CARBOMER HOMOPOLYMER TYPE C
DIISOPROPYL ADIPATE
EDETATE DISODIUM
HEXYLENE GLYCOL
METHYLPARABEN
OLEYL ALCOHOL
POLYSORBATE 80
PROPYLPARABEN
WATER
SODIUM CITRATE
SODIUM HYDROXIDE
SORBITAN TRISTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-4052-89 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (0591-4052-89)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210019 10/14/2019
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 01/2019 Actavis Pharma, Inc.

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