Label: HOMEOPATHIC TEA TREE OIL LICE- eucalyptus globulus, natrum muriaticum shampoo shampoo
- NDC Code(s): 44038-0192-1
- Packager: Accupac, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 2, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingedients
- Purpose
- Uses
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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 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.
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Directions
Adults and children 2 years and older:
Apply 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.
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Inactive Ingredients
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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SPL UNCLASSIFIED SECTION
DG Health
Homeopathic
Tea Tree Oil
Lice Shampoo
Daily shampoo kills stray super lice before detected
Kills newly contracted lice or lice missed in a treatment with every wash
Deters and infestation from taking hold
100% Satisfaction Guaranteed!(888)309-9030
Distributed by
Old East Main Co.
100 Mission Ridge
Goodlettsville, TN 37072
Made in the U.S.A
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HOMEOPATHIC TEA TREE OIL LICE
eucalyptus globulus, natrum muriaticum shampoo shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44038-0192 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 2 [hp_X] in 1 mL EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981) COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q) WATER (UNII: 059QF0KO0R) PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM) BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYL LACTATE (UNII: 0UI63W814U) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8) EDETATE SODIUM (UNII: MP1J8420LU) GERANIOL (UNII: L837108USY) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44038-0192-1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2024 Labeler - Accupac, LLC (071609663)
