Active Ingredient
Active ingredient (in each fluid ounce)
Permethrin 280 mg (1%)
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Lice Treatment (NDC 42254-065). 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, on children under 2 months of age, ask a doctor before use if you are, when using this product, eye irritation occurs, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each fluid ounce)
Permethrin 280 mg (1%)
Lice treatment
Treats head lice
For external use only
Ask a doctor before use if you are
When using this product
Stop use and see a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions? 1-800-432-8534 (select option # 2).
Form No. 5242-PI
Rev. 8/08
VC 3202
If pregnant or breast-feeding, ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
Other information
Balsam fir canada, cetyl alcohol, citric acid, FD&C yellow #6, fragrance, hydrolyzed
animal protein, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polyoxyethylene
10 cetyl ether, propylene glycol, propylparaben, purified water, stearalkonium chloride
1-800-432-8534 (select option # 2) between 9 am and 4 pm EST, Monday – Friday.
Single Application
Lice Treatment
Permethrin Lotion 1%
With A Single Application:
Creme Rinse With Nit Removal Comb
2 FL OZ (59 mL)
Consumer Information Insert
Permethrin Lotion 1%
Lice Treatment
Please read all information before using Permethrin Lotion 1%.
If you or a member of your household has 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?
Because nits (eggs) hatch in about one week, all nits must be removed to stop lice.
How do head lice spread?
How do you know if you have lice?
How do you prevent the spread of lice?
How to use Permethrin Lotion 1%
If you suspect head lice – check. Head lice may be hard to locate because they avoid light. Nits are easier to see.
Treatment kills lice but does not remove the nits.
After using Permethrin Lotion 1%, it is very important to clean personal items and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about 1 day.
WARNINGS
For external use only
Do not use
* Please review the disclaimer below.