IVERMECTIN- ivermectin lotion 
Taro Pharmaceuticals U.S.A., Inc.

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Ivermectin

Drug Facts

Active ingredient

Ivermectin 0.5%

Purpose

Lice treatment

Use

treats head lice

Warnings

For external use only. Use only on the scalp.

Do not use

  • on children under 6 months of age
  • near the eyes
  • inside the nose, ear, mouth, or vagina
  • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Ask a doctor before use if you

  • have any skin conditions or sensitivities
  • are pregnant or plan to become pregnant. It is not known if product can harm your unborn baby.
  • are currently or planning to breastfeed. Avoid getting product on your breast to help prevent contact by your baby.

When using this product

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into eyes, gently flush with water
  • eye redness, soreness, or irritation can occur
  • dandruff, dry skin, or burning sensation of the skin can occur

Stop use and ask a doctor if

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs
  • rash develops

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Important: Read warnings before use

Inspect

Treat

Wait and rinse

After treatment

Other information

Inactive ingredients

butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl alcohol.

Questions?

1-866-923-4914

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.

Hawthorne, NY 10532

Ivermectin Lotion, 0.5%
Lice Treatment Lotion

THE FACTS OF LICE

Please read all information before using Ivermectin Lotion.

If you or a member of your household has head lice, don't panic. Keep calm.

Anyone can get head lice – it has nothing to do with cleanliness or poor hygiene. Head lice are treatable and very rarely cause serious health problems.

What are head lice?

What are nits?

How do head lice spread?

How do you know if you have lice?

How do you prevent the spread of lice?

How do I use Ivermectin Lotion?

Important: Read warnings before use

Inspect

Treat

Figure A

figure A

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

figure B

Figure C

figure C

Figure D

figure D

Wait and rinse

Figure E

figure E

Figure F

figure F

After treatment

WARNINGS

For external use only. Use only on the scalp.

Do not use

Ask a doctor before use if you

When using this product

Stop use and ask a doctor if

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Questions or comments? Call 1-866-923-4914

Mfd. by: Taro Pharmaceutical Industries Ltd.
Haifa Bay, Israel 2624761
Made in Israel

Issued: November 2020

PRINCIPAL DISPLAY PANEL - 117 g Tube Carton

Compare to the
active ingredient
in Sklice®

NDC 51672-4230-8

Ivermectin
Lotion, 0.5%
Lice Treatment

Original Prescription Strength

Now available without
a prescription!

One tube, one time,
10 minutes!

IVERMECTIN LOTION KILLS LICE

No nit combing required
No second application required

Includes:
1 Tube
Net Wt. 4 oz (117 g)

PRINCIPAL DISPLAY PANEL - 117 g Tube Carton
IVERMECTIN 
ivermectin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-4230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ivermectin (UNII: 8883YP2R6D) (Ivermectin - UNII:8883YP2R6D) Ivermectin5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
butylated hydroxyanisole (UNII: REK4960K2U)  
castor oil (UNII: D5340Y2I9G)  
cetyl alcohol (UNII: 936JST6JCN)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
cyclomethicone (UNII: NMQ347994Z)  
glycerin (UNII: PDC6A3C0OX)  
imidurea (UNII: M629807ATL)  
lanolin alcohols (UNII: 884C3FA9HE)  
methylparaben (UNII: A2I8C7HI9T)  
oleyl alcohol (UNII: 172F2WN8DV)  
olive oil (UNII: 6UYK2W1W1E)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
shea butter (UNII: K49155WL9Y)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
sorbitan tristearate (UNII: 6LUM696811)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Product Characteristics
ColorWHITE (off-white;tan) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-4230-81 in 1 CARTON01/06/2021
1117 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21072005/06/2020
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(51672-4230)

Revised: 8/2022
Document Id: b9664cbb-1e38-4caa-8780-6f0ae6ed0712
Set id: dd2c66e6-bd50-46df-a335-26215d02d13b
Version: 3
Effective Time: 20220823
 
Taro Pharmaceuticals U.S.A., Inc.