Otc - Active Ingredient
Ivermectin 0.5%
Head Lice Treatment Ivermectin Lotion118ml Lotion/shampoo
FDA Label NDC 84763-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Head Lice Treatment Ivermectin Lotion118ml (NDC 84763-015). 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 - 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
Otc - Purpose
Lice treatment
Indications & Usage
Treats head lice.
Warnings
For external use only.
Otc - Do Not Use
Do not use on broken or severely irritated skin.
Otc - When Using
When using this product
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Use only on the scalp and hair.
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
use only on scalp and hair
Otc - Stop Use
Stop use and ask a doctor if
Skin irritation, redness, or rash develops and persists.
Signs of an allergic reaction occur.
Head lice remain after treatment or symptoms worsen.
breathing difficulty occurs
eye irritation occurs
skin or scalp irritation continues or infection occurs rash develops
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Ask Doctor/Pharmacist
have any skin conditions or sensitivities
are pregnant or plan to become pregnant
are currently or planning to breastfeed
Dosage & Administration
Children 6 months to under 12 years of age: Adult supervision is required.
Adults and children 6 months of age and over:
hair and scalp must be dry before applying product apply enough lotion to completely cover dry hair and scalp
completely cover the scalp and hair closest to the scalp first, then apply outward toward the ends of the hair rub product throughout hair
leave on hair and scalp for 10 minutes after hair and scalp are completely covered
after 10 minutes, rinse product completely from hair and scalp using only water
after rinsing, dry and style hair as usual
wait 24 hours before applying shampoo
nit combing is not necessary for treatment to work, but a fine-tooth comb may be used to remove dead lice and nits if desired
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
Inactive Ingredient
Water
Caprylic/Capric Triglyceride
Glycerin
Cetearyl Alcohol
Glyceryl Stearate
PEG-100 Stearate
Cetyl Alcohol
Dimethicone
Panthenol
Allantoin
Aloe Barbadensis Leaf Juice
Tocopherol
Carbomer
Disodium EDTA
Phenoxyethanol
Ethylhexylglycerin
Package Label.Principal Display Panel
Label3 (Label3)
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