Active Ingredients
Eucalyptus globulus 2X (HPUS)
Natrum muriaticum 2X (HPUS)
Homeopathic Tea Tree Oil Lice Shampoo
FDA Label NDC 55910-192
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Llc for the product Homeopathic Tea Tree Oil Lice (NDC 55910-192). 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 active ingredients, purpose, warnings, otc - keep out of reach of children, directions:, inactive ingredients, questions?, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pediculicide
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.
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