Active Ingredient
Ivermectin 0.5%
Nicovito Ivermectin Lotion. Lotion
FDA Label NDC 83091-004
14 label sections · Submitted to the FDA by Anhui Cao Coral Biology Science And Technology Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anhui Cao Coral Biology Science And Technology Co., Ltd for the product Nicovito Ivermectin Lotion. (NDC 83091-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lice Treatment
Use
treats head lice
Warnings
For external use only
Do Not Use
Do not use if you are allergic to ivermectinor any of the ingredients in this product.
When Using
avoid contact with eyes. If contact occurs,rinse thoroughly with water.
do not use on eyebrows or eyelashes.
do not use on broken or irritated scalp.
Stop Use
irritation, redness, or rash occurs.
condition persists or worsens.
Ask Doctor
irritation, redness, or rash occurs.
condition persists or worsens.
Keep Out Of Reach Of Children
If swallowed, get medical help or contacta Poison Control Center right away.
Directions
Check hair for live lice before use.
Apply enough lotion to thoroughly coat dry hair
and scalp.
Leave on for 10 minutes.
Rinse thoroughly with water.
Towel dry. No nit combing required*.
Use only once per treatment cycle unless
directed by a doctor.
Other Information
Store at 20°Cto 25°C (68°F to 77°F).
Keep tightly closed.
Do not freeze.
Protect from excessive heat.
Inactive Ingredients
butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, cyclomethicone, glycerin, imidurea, lanolin alcohols, crodalan AWS, sorbitan tristearate, methylparaben, oleyl alcohol, olive oil, propylene glycol, stearyl alcohol, propylparaben, purified water, shea butter, sodium citrate anhydrous.
Questions
Principal Display Panel
83091-004
1 (Pack)
* Please review the disclaimer below.
