FDA Label for Lice Treatment Dedicated
View Indications, Usage & Precautions
Lice Treatment Dedicated Product Label
The following document was submitted to the FDA by the labeler of this product Shenzhen Zhenshangzekai Technology Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
lice treatment
lice treatment
Otc - Active Ingredient
ivermectin
Otc - Ask Doctor
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 product can harm your unborn baby.
Are currently or planning to breast feed!
Avoid getting product on your breast to help prevent contact by your baby.
Otc - Do Not Use
-Breathing difficulty occurs
-Eye irritation occurs
-Skin or scalp irritation continues or infection occurs
-Rash develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center(1-800-222-1222)right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Questions
925-899-0135
Warnings
TAMPER EVIDENT: DO NOT USE IF THEPUMP IS DAMAGED OR SEAL IS BROKEN. Store at room temperature 68℃F-77°
Do not freeze.
keep carton and see Consumer Information Leaflet and warnings before use
Dosage & Administration
lotion, topical
Inactive Ingredient
Butylated hydroxyanisole, castor oil, cetylalcohol, citric acid anhydrous, crodalan AWS,cyclomethicone, glycerin, imidurea, lanolinalcohols, methylparaben, oleyl alcohol, oliveoil, propylene glycol, propylparaben, purifedwater, shea butter, sodium citrate anhydroussorbitan tristearate and stearyl alcohol.
Indications & Usage
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 houschold members should be checked by anothe!person for lice and/or nits (eggs)
Use a magnifying glassin bright light to help you see
thelice and/or nits(eggs)
Use a tool, such as a comb or two unsharpened pencilsto lift and part the hair
Look for tiny nits near the scalp, beginning at the backof theneck and behind the ears
Examine small sections ofthe hair (1-2 inches wide) ata time
.Unlike dandruff, nits stick to the hair, Dandruff shouldmove when lightly touched
If either lice or nits (eggs) are found, treat with product
Treat
Your hair and scalp must be DRY before applyingproduct
Apply the product directly onto dry hair and scalp
Completely cover your scalp and hair closest to thescalp first.and then apply outwards towards the endsofyour hair
Use only as much asneeded to fully cover hair andscalp up to one full bottle, and discard the remainingRub product throughout your hair
Itis important to completely cover your entire head sothat all lice and eggs are exposed to the lotion, Be surethat each hair is coated from the scalp to the tip
Wait and Rinse
Allow product to stay on your hair and scalp for 10minutes after it has been applied, Use a timer or clockStart timing after you have completely covered yourhair and scalp with product.
After 10 minutes, rinse product completely from youhair and scalp using only water.
After rinsing, dry and style hair as usual. Wait 24 hoursbefore applying shampoo.
After treatment
Wash your hands after applying product.
-Nit combing is not necessary whentreating with product for it to work, but ifdesired, a fne-tooth comb or special nitcomb may be used to remove dead liceand nits.This is a single use product, Discard
bottle after use.Do not use again on the same personand same lice infestation without talkingto a healthcare provider frst.If infestation continues, see a doctor forother treatments.
Machine wash any bedding and clothingused by anyone having lice, Machinewash at high temperatures (150°F) andtumble in a hot dryer for 20 minutes.After fnishing treatment with licemedicine, check everyone in your famillyfor lice after one week. Considertreatment for those who have lice.
Package Label.Principal Display Panel
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