Ivermectin (Page 3 of 3)

Instructions for Use

Before you use Ivermectin Lotion, it is important that you read the Patient Information and these Instructions for Use. Be sure that you read, understand, and follow these Instructions for Use so that you use Ivermectin Lotion the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use Ivermectin Lotion.

  • Your hair and scalp must be dry before applying Ivermectin Lotion.

Figure AFigure A

  • Use the top of cap to break the tamper seal on the tube (see Figure A).

Figure BFigure B

Figure CFigure C

Figure DFigure D

  • Apply Ivermectin Lotion directly to dry hair and scalp (see Figure B).
  • Completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair (see Figure C).
  • Rub Ivermectin Lotion throughout your hair (see Figure D).
  • It is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip.
  • Use up to 1 entire tube (4 oz) to completely cover hair and scalp.

Figure EFigure E

Figure FFigure F

  • Allow Ivermectin Lotion to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with Ivermectin Lotion (see Figure E).
  • After 10 minutes, completely rinse Ivermectin Lotion from your hair and scalp using only water (see Figure F).
  • You or anyone who helps you apply Ivermectin Lotion should wash their hands after application.
  • It is recommended to wait 24 hours before applying shampoo to hair and scalp.
  • Do not use Ivermectin Lotion again without talking to your healthcare provider first.
  • How do I stop the spread of lice?

To help prevent the spread of lice from one person to another, here are some steps you can take:

  • Avoid direct head-to-head contact with anyone known to have live, crawling lice.
  • Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not.
  • Avoid sleepovers and slumber parties during lice outbreaks. Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice.
  • After finishing treatment with lice medicine, check everyone in your family for lice after one week. Be sure to talk to your healthcare provider about treatments for those who have lice.
  • Machine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Issued: December 2019

PRINCIPAL DISPLAY PANEL — 117 g Tube Carton

Net wt.:
4 oz (117 g)

NDC 51672-4211-8

Ivermectin
Lotion 0.5%

FOR TOPICAL USE
ON THE SCALP HAIR
AND SCALP ONLY.

FOR SINGLE USE.
DISCARD THE TUBE
AFTER USE.

Warning:
Keep out of reach of children.
Use in children should be
under the direct supervision
of an adult.
Do not swallow.Avoid eye contact.

Rx only

TARO

PRINCIPAL DISPLAY PANEL -- 117 g Tube Carton
(click image for full-size original)
IVERMECTIN ivermectin lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4211
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ivermectin (Ivermectin) Ivermectin 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
butylated hydroxyanisole
castor oil
cetyl alcohol
ANHYDROUS CITRIC ACID
cyclomethicone
glycerin
imidurea
lanolin alcohols
methylparaben
oleyl alcohol
olive oil
propylene glycol
propylparaben
water
shea butter
ANHYDROUS TRISODIUM CITRATE
sorbitan tristearate
stearyl alcohol
Product Characteristics
Color WHITE (off-white /tan) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4211-8 1 TUBE in 1 CARTON contains a TUBE
1 117 g in 1 TUBE This package is contained within the CARTON (51672-4211-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210720 05/06/2020
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries, Ltd. 600072078 MANUFACTURE (51672-4211)

Revised: 05/2020 Taro Pharmaceuticals U.S.A., Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.