Otc - Active Ingredient
Ivermectin 0.5%
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Scalp Care Lotions (NDC 87278-015). 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 - do not use, otc - ask doctor, 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
Lice treatment
For external use only. Use only on the scalp.
near the eyes
on children under 6 months of age
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
breathing difficulty occurs
eye irritation occurs
skin or scalp iritation continues or infection occurs
rash develops
If pregnant or breastfeeding, ask a health
professional before use.
KEEP OUT OF REACH OF CHILDREN SECTION
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:
all household members should be checked by another person for lice and/or nits (eggs)
use a magnifying glass in bright light to help you see the lice and/or nits (eggs)
use a tool, such as 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 the hair (1-2 inches wide) at a time
unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.
if either lice or nits (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 using only water
after rinsing, dry and style as usual. Wait 24 hours before applying shampoo.
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 nits
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 treat
mentsmachine 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
cetylalcohol
anhydrous citric acid
cyclomethicone
glycerin
imidurea
lanolin alcohols
methylparaben
oleylalcohol
olive oil
propylene glycol
propylparaben
purified water
sheabutter
sodium citrate anhydrous
sorbitantristearate
stearyl alcohol
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