Active Ingredient(S)
Ivermectin 0.5%
Bldaxn Ivermectin Lotion0.5% Emulsion
FDA Label NDC 84558-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yusong Fine Chemicls Co., Ltd for the product Bldaxn Ivermectin Lotion0.5% (NDC 84558-024). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - 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
Use
Use treats head lice
Warnings
For external use only. Use only
on the scalp
Do Not Use
on children under 6months
near eyes
in nose, ears, mouth, or vagina
on lice in eyebrows or eyelashes
Otc - When Using
keep eyes closed and protected
rinse with water if contact occurs
temporary eye irritation, dryness, burning, or dandruff may occur
Otc - Stop Use
eye irritation or breathing difficulty occurs
skin/scalp irritation persists or worsens
rash or infection develops
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help
or call Poison Control at
1-800-222-1222.
Directions
Important: Read warnings before use.
Children
·Children 6 months to under 12 years: use under adult supervision
Step 1: Inspect
. Use bright light and a magnifying tool to help detect lice and nits
. Part hair into small sections and examine close to the scalp, especially behind ears and at the nape of the neck
. Check all household members for lice and/or nits (eggs)
. Nits are firmly attached to hair shafts and do not flake off like dandruff
. If lice or nits are present, proceed to treatment
Step 2: Treat
. Hair and scalp must be DRY before use
. Check inner seal before first use. Do not use if seal is broken or missing
. Attach pump, unlock, and dispense product into hands
. Apply evenly to scalp and hair, starting at the scalp and working to the ends
. Ensure complete coverage of hair and scalp
. Use only the amount needed to fully cover hair and scalp. Discard any unused product after treatment
· Wash hands after application
Step 3: Wait & Rinse
. Leave product on hair and scalp for 10 minutes
. Start timing after full application
. After 10 minutes, rinse thoroughly with water only
. Dry and style as usual
· Wait 24 hours before using shampoo
After treatment
. Nit combing is optional and may be used to remove dead lice and eggs
. This product is for single use only. Discard bottle after use
. If lice persist, consult a healthcare provider
. Wash bedding, clothing, and personal items in hot water and dry on high heat
· Recheck al household members after 7 days; treat only if necessary
Other Information
TAMPER EVIDENT:Do not use if inner seal under cap is broken or missing.
. Store at room temperature: 68°F-77°F (20°C-25°C).
. Do not freeze.
. Keep carton for full information.
Inactive Ingredients
butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan
AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oley| alcohol,
olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate
anhydrous, sorbitan tristearate and stearyl alcohol
Package Label - Principal Display Panel
Undefined (Label)
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