Otc - Active Ingredient
Ivermectin 0.5%
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Zhouyu Xingchen Technology Co., Ltd. for the product Vivoclear Lvermectin Lice Treatment (NDC 88025-001). 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, indications & usage, warnings, otc - keep out of reach of children, otc - do not use, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ivermectin 0.5%
Lice Treatment
Treats head lice
For external use only.
Use only on the scalp.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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.
have any skin conditions or sensitivities
are pregnant or plan to become pregnant. It is not known if product can harm your unborn baby.
are currently or planning to breastfeed. Avoid getting product on your breast to help prevent contact by your baby.
keep eyes tightly closed and protect eyes with a washcloth or towel
if product gets into eyes, gently flush with water
eye redness, soreness, or irritation can occur
dandruff, dry skin, or burning sensation of the skin can occur
Directions
Important: Read warnings before use
children 6 months of age to under 12 years of age: an adult should supervise use
adults and children 6 months of age and over:
Inspect
all household members should be checked by another person for live and/or nils (eggs)
use a magnifying glass in bright light to help you see the live and/or nils (eggs)
use a tool, such as a comb or two unsharpened pencils to lift and part the hair
look for tiny nils near the scalp, beginning at the back of the neck and behind the ears
examine small sections of the hair (1-2 inches wide) at a time
unlike dandruff, nils stick to the hair. Dandruff should move when lightly touched.
if either lice or nils (eggs) are found, treat with product
Treat
your hair and scalp must be DRY before applying product
use the top of cap to break the tamper seal on the tube
apply product directly to dry hair and scalp
completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair
use only amount needed to completely cover hair and scalp, up to 1 entire tube, and discard the remaining
rub product throughout your hair
it is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip.
Wait and rinse
allow product to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with product.
after 10 minutes, rinse product completely from your hair and scalp
After treatment
wash your hands after applying product
nit combing is not necessary when treating with product for it to work, but if desired, a fine-tooth comb or special nit comb may be used to remove dead lice and nils
this is a single use product. Discard tube after use.
do not use again on the same person and 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 having lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.
after finishing treatment with lice medicine, check everyone in your family for lice after one week. Consider treatment for those who have lice.
butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate, stearyl alcohol
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