Vanalice Piperonyl butoxide, Pyrethrum 35 mg/mL; 3 mg/mL Gel, 237 mL
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and children 2 years of age and older. Pyrethrin and piperonyl butoxide is in a class of medications called pediculicides. It works by killing lice.
Read the full MedlinePlus article ↗- It treats lice — specifically head lice, pubic (sometimes called crab) lice, and body lice. You apply it directly to the affected area of skin or hair, not take it by mouth. It's n...
- You leave it on for exactly 10 minutes — no longer — then wash it off with warm water and soap or shampoo. And yes, the second treatment 7 to 10 days later is really important. It...
- How long do I leave it on, and do I really need a second treatment?
- Combing is a key part of the treatment. After rinsing, towel-dry your hair and use a fine-tooth lice comb while the hair is still slightly damp. Work through sections starting at t...
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
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A fragrant compound derived from citronella oil or synthetically made. Used as a flavor and aroma agent to make the medicine taste or smell pleasant.
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Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
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DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
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Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
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A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
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Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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A natural essential oil extracted from lemongrass plants, used as a flavoring and fragrance agent to improve the taste and smell of the medicine.
10 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.168 | $39.70 / 237 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1721 | $40.79 / 237 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vanalice 35 mg/mL; 3 mg/mLthis 58809-0650-08 | GM | 237 ml | $0.168 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58809-0650-08 You're viewing this | 237 mL in 1 BOTTLE (58809-650-08) | 2018-08-05 | Active |
📄 FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses treats head, pubic (crab), and body lice
⏱️ Dosage and Administration ▾
Directions Important: Read warnings before use Adults and children 2 years and over: Inspect check each household member with a magnifying glass in bright light for lice/nits (eggs) look for tiny nits near scalp, beginning at back of neck and behind ears examine small sections of hair at a time unlike dandruff which moves when touched, nits stick to the hair if either lice or nits are found, treat with this product Treat apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck. allow product to remain for 10 minutes, but no longer wash area thoroughly with warm water and soap or shampoo for head lice, towel dry hair and comb out tangles Remove lice and their eggs (nits) use a fine-tooth or special lice/nit comb.
Remove any remaining nits by hand (using a throw-away glove). hair should remain slightly damp while removing nits if hair dries during combing, dampen slightly with water for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours. lift a 1-to 2-inch wide strand of hair.
Place comb as close to scalp as possible and comb with a firm, even motion away from scalp. pin back each strand of hair after combing clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back. after combing, thoroughly recheck for lice/nits.
Repeat combing if necessary. check daily for any lice/nits that you missed a second treatment must be done in 7 to 10 days to kill any newly hatched lice if infestation continues, see a doctor for other treatments Children under 2 years: ask a doctor
⚠️ Warnings ▾
For external use only near eyes inside nose, mouth, or vagina on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas. if you have ever had an allergic reaction to this product or any of its ingredients allergic to ragweed. May cause breathing difficulty or an asthmatic attack. keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, flush with water right away scalp itching or redness may occur breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs If swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Piperonyl butoxide 3.5% Pyrethrum extract (equivalent to 0.3% pyrethrins)
🧪 Inactive Ingredients ▾
carbomer, citronellyl acetate, coconut oil, DMDM hydantoin, peg40-hydrogenated castor oil, isopropanol, isopropyl myristate, lemongrass oil, purified water, sodium hydroxide, tea tree oil tocopheryl acetate (vitamin E)
🎯 Purpose ▾
Lice treatment