FDA Label for Vamousse Lice Defense

View Indications, Usage & Precautions

Vamousse Lice Defense Product Label

The following document was submitted to the FDA by the labeler of this product Alliance Pharma Inc.. 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.

Drug Facts




Active Ingredients



Eucalyptus globulus 2X (HPUS)

Natrum muriaticum 2X (HPUS)


Purpose



Pediculicide


Uses



For daily defense against head lice infestations.


Warnings



For external use only.

Do not use • near eyes • inside nose or mouth • on eyebrows or eyelashes. See a doctor if lice are present in these areas. Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

When using this product:

• Do not use in or near the eyes. Close eyes while applying.

• Do not permit contact with mucous membranes, such as inside the nose, as irritation or stinging may occur.

Stop use and ask a doctor • if eye irritation occurs • skin or scalp irritation or infection occurs.

If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions:



Adults and children 2 years and older:

• Apply a generous amount of shampoo to wet hair, work into a lather and massage into scalp. Leave shampoo in hair for at least 3 minutes. Rinse.

• For defense against a head lice infestation, use daily for at least 10 to 14 days to kill any lice that may have hatched.

• For an active head lice infestation, use Vamousse® Lice Treatment before using this shampoo.

Children under 2 years: ask a doctor.

Product may be used as often as needed.


Inactive Ingredients



Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Cocoyl Isethionate, Cocamide DIPA, Benzyl Alcohol, Butyl Lactate, Citric Acid Anhydrous, Polyquaternium-10, Tetrasodium EDTA, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, PEG-150 Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Glycerides, Tea Tree Oil, Eucalyptus Oil, Geraniol, Isopropyl myristate, Fragrance


Questions?



1.855.373.7210 or www.VamousseLice.com

Call to report serious side effects


Packaging




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