Permethrin 1%
Permethrin 1%
Kakshal Permethrin Lotion
FDA Label NDC 87544-8526
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kakshal for the product Kakshal Permethrin (NDC 87544-8526). 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 permethrin 1%, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lice treatment
Uses
Treats head lice
Warnings
For external use only.
Do Not Use
• Do not use in or near the eyes
• Do not use on children under 2 months of age unless directed by a doctor
When Using This Product
• Keep out of eyes
• If product gets into eyes, flush immediately with water
• Scalp itching or redness may occur
Stop Use And Ask A Doctor If
• Breathing difficulty occurs
• Eye irritation continues
• Skin irritation or infection occurs
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Other Information
Store at 20°–25°C (68°–77°F)
Avoid excessive heat
Inactive Ingredients
Cetearyl alcohol, cetomacrogol 1000, fragrance, glycerin,
glyceryl monostearate, mineral oil, methylparaben,
polysorbate 20, polysorbate 80, propylparaben, purified water
Directions
• Wash hair with regular shampoo, rinse, and towel dry
• Apply enough lotion to completely cover hair and scalp, especially behind ears and back of neck
• Leave on for 10 minutes
• Rinse thoroughly with warm water
• Use a fine-tooth comb to remove remaining nits
• Check hair after 7 days
• If live lice are observed seven days or more after first treatment, a second application must be used
Principal Display Panel
KAKSHAL
Lice Treatment
Permethrin Lotion 1%
✔ Treats head lice
✔ Easy-to-apply lotion
✔ Helps remove nits with a fine-tooth comb
Topical Lotion
Net Contents: 2 fl oz (60 mL)
* Please review the disclaimer below.
