Ivermectin (Page 3 of 3)
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
Patients using ivermectin cream should receive the following instruction:
Keep out of reach of children.
Manufactured By:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
Rev. B 11/2022
INSTRUCTION FOR USE
Ivermectin (eye” ver mek’ tin) Cream, 1%
Important: Ivermectin cream is for use on the skin only (topical use). Do not use ivermectin cream in your mouth, eyes, 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.
Figure A 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.
Figure C
3. Apply ivermectin cream to the affected areas of your face 1 time 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.
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 and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured By:
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
Rev. B 11/2022
PATIENT INFORMATION
Ivermectin (eye” ver mek’ tin) Cream, 1% |
Important: Ivermectin cream is for use on the skin only (topical use). Do not use ivermectin cream in your mouth, eyes, or vagina. |
What is ivermectin cream? Ivermectin cream is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea. It is not known if ivermectin cream is safe and effective in children. |
Before using ivermectin cream, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
How should I use ivermectin cream? See the detailed “Instructions for Use” that comes with ivermectin cream for information on how to apply ivermectin cream.
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What are the possible side effects of ivermectin cream? The most common side effects of ivermectin cream include skin burning sensation and skin irritation. These are not all of the possible side effects of ivermectin cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Teva at 1-888-838-2872. |
How should I store ivermectin cream?
Keep ivermectin cream and all medicines out of the reach of children. |
General information about the safe and effective use of ivermectin cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ivermectin cream for a condition for which it was not prescribed. Do not give ivermectin cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ivermectin cream that is written for health professionals. |
What are the ingredients in ivermectin cream? Active ingredient: ivermectin Inactive ingredients: benzyl alcohol, citric acid anhydrous, carbomer homopolymer type c, di-isopropyl adipate, edetate disodium, hexylene glycol, methylparaben, oleyl alcohol, polysorbate 80, propylparaben, purified water, sodium citrate, sodium hydroxide, and sorbitan tristearate |
Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 For more information, call Teva at 1-888-838-2872. |
This Patient Information has been approved by the U.S. Food and Drug Administration. Rev. A 11/2022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0591-4052-89
Ivermectin Cream 1%
45 GRAMS
FOR TOPICAL USE ONLY
Not for Oral, Ophthalmic, or Intravaginal Use
Rx only
IVERMECTIN ivermectin cream | ||||||||||||||||||||||||||||||||
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Labeler — Actavis Pharma, Inc. (119723554) |
Revised: 11/2022 Actavis Pharma, Inc.
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