VAMOUSSE PRO LICE TREATMENT- sodium chloride liquid

Vamousse Pro Lice Treatment by

Drug Labeling and Warnings

Vamousse Pro Lice Treatment by is a Homeopathic medication manufactured, distributed, or labeled by Tyra Tech, Inc., Tropical Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Natrum muriaticum 2X (HPUS)

Purpose

Homeopathic pediculicide

Uses

Treats head lice

Warnings

For external use only

Do not use

• near eyes
• inside nose
• mouth
• vagina
• eyebrows or eyelashes.

See a doctor if lice are present in these areas.

When using this product:

• Keep eyes tightly closed and protect eyes with a washcloth or towel.
• If product gets in eyes, flush with water right away.
• Scalp itching or redness may occur.

Stop use and ask a doctor if eye irritation occurs, skin or scalp irritation continues or infection occurs. If pregnant or breastfeeding, 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.

• Separate hair into sections, working with 1 inch sections at a time following your normal combing procedure.
• Thoroughly saturate all hair and scalp as you work, massaging product into the hair generously. To be effective, all lice and nits must come in contact with the product. Note: dilution may reduce efficacy.
• Use approximately 2 fl oz (2 – 3 pumps) of lotion for an average head of hair.
• If product needs to be thinned for particular hair type, use a spray bottle to lightly spritz the hair with water, allowing lotion to spread more easily.
• Using a lice/nit comb, comb hair from as close to the scalp as possible to the end of the hair.
• If hair dries during combing, apply more product or use a spray bottle to lightly spritz the hair with water, rehydrating the lotion.
• After combing, thoroughly recheck for lice/nits. Repeat combing if necessary.

Product may be used as often as needed. Children under 2 years old: ask a doctor.

Other Information

Store between 59-86°F (15 -30°C).

Inactive Ingredients

Benzyl alcohol, Butyl lactate, Cetearyl alcohol, Cetrimonium chloride, DMDM Hydantoin, Fragrance, Isopropyl alcohol, Isopropyl myristate, Magnesium chloride, Magnesium nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Peppermint oil, Triethyl citrate, Water

Questions?

1.855.373.7210 or www.VamousseLice.com

PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label

NDC: 58962-010-01

VAMOUSSE®

Pro

• Non-toxic
• Pesticide-free
• Facilitates combing for
  lice and nit removal
• Dehydrates lice AND
  eggs with safe
  ingredients

FOR LICE TREATMENT
PROFESSIONALS

HOMEOPATHIC
32 FL OZ (946 ML)

INGREDIENTS AND APPEARANCE

VAMOUSSE PRO LICE TREATMENT 
sodium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58962-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	2 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYL LACTATE (UNII: 0UI63W814U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GERANIOL (UNII: L837108USY)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEPPERMINT OIL (UNII: AV092KU4JH)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58962-010-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		09/25/2015

Labeler - Tyra Tech, Inc. (782845882)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Products, Inc.		157469086	MANUFACTURE(58962-010) , LABEL(58962-010)