Otc - Active Ingredient
Ivermectin 0.5%
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xuyan Technology Co., Ltd. for the product Synthabio Ivermectin (NDC 87782-001). 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 otc - active ingredient, otc - purpose, inactive ingredient, otc - ask doctor, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ivermectin 0.5%
Lice treatment
Butylated hydroxyanisole, castor oil, cetyl alcohol, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate, stearyl alcohol.
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 this product can harm your unborn baby)
are currently breastfeeding or plan to breastfeed (avoid getting product on your breast to prevent contact by your baby)
For external use only. Use only on the scalp.
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)
Keep your eyes tightly closed and protect yourself with a washcloth or towel
If product gets into eyes, gently flush with water
Eye redness or irritation may occur
Dandruff, dry skin, or burning sensation may occur
breathing difficulty occurs
eye irritation occurs
skin or scalp irritation continues, or infection occurs
rash develops
Important: Read warnings before use
Age supervision:
Children 6 months to under 12 years: an adult should supervise use.
Adults and children 6 months and over: use as directed.
Inspect:
Have another person check all household members for lice and/or nits (eggs).
Use a comb or two unsharpened pencils to lift and part the hair.
Look for tiny nits near the scalp, beginning at the back of the neck and behind the ears.
Examine small sections of hair (1–2 inches wide) at a time.
Unlike dandruff, nits stick to the hair. Dandruff moves when lightly touched.
If lice or nits are found, treat with this product.
Treat:
Hair and scalp must be dry before applying product.
Use the top of the cap to break the tamper seal on the tube.
Apply product directly to dry hair and scalp.
Wait and rinse:
Leave product on hair and scalp for 10 minutes after application. Use a timer or clock. Start timing after you have completely covered your hair and scalp.
After 10 minutes, rinse product completely from hair and scalp using only water.
After rinsing, dry and style as usual. Wait 24 hours before applying shampoo.
After treatment:
Wash hands after applying the product.
Not combing is not necessary for the product to work. If desired, use a fine-tooth comb or special nit comb to remove dead lice and nits.
This is a single-use product. Discard tube after use.
Do not use again on the same person for the same lice infestation without talking to a healthcare provider first.
If infestation continues, see a doctor for other treatments.
Machine wash any bedding and clothing used by anyone with lice. Wash at high temperature (150°F) and tumble in a hot dryer for 20 minutes.
After finishing treatment, check everyone in your family for lice after one week. Consider treatment for those who have lice.
Treats head lice
Keep out of reach of children
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