Label: HOMEOPATHIC TEA TREE OIL LICE- eucalyptus globulus, natrum muriaticum shampoo
- NDC Code(s): 55910-192-01
- Packager: DOLGENCORP, 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 November 15, 2023
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- Drug Facts
- Active Ingredients
- 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 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.
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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.
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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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INGREDIENTS AND APPEARANCE
HOMEOPATHIC TEA TREE OIL LICE
eucalyptus globulus, natrum muriaticum shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-192 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 2 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8) COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q) TEA TREE OIL (UNII: VIF565UC2G) BENZYL ALCOHOL (UNII: LKG8494WBH) EUCALYPTUS OIL (UNII: 2R04ONI662) BUTYL LACTATE (UNII: 0UI63W814U) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981) GERANIOL (UNII: L837108USY) EDETATE SODIUM (UNII: MP1J8420LU) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-192-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/15/2023 Labeler - DOLGENCORP, LLC (068331990) Establishment Name Address ID/FEI Business Operations Accupac, LLC 061595175 manufacture(55910-192)
