HOMEOPATHIC TEA TREE OIL LICE- eucalyptus globulus, natrum muriaticum shampoo 
DOLGENCORP, LLC

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.

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Homeopathic Tea Tree Oil Lice Shampoo

Drug Facts

Active Ingredients

Eucalyptus globulus 2X (HPUS)

Natrum muriaticum 2X (HPUS)

Purpose

Pediculicide

Uses

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.

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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Packaging

label

HOMEOPATHIC TEA TREE OIL LICE 
eucalyptus globulus, natrum muriaticum shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE2 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-192-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/15/2023
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, LLC061595175manufacture(55910-192)

Revised: 11/2023
Document Id: 0a35f0c9-696d-e38a-e063-6294a90afb5c
Set id: 0a0c2db2-7eeb-909c-e063-6394a90a7a90
Version: 2
Effective Time: 20231115
 
DOLGENCORP, LLC