VAMOUSSE LICE PREVENTION- sodium chloride shampoo

Vamousse Lice Prevention by

Drug Labeling and Warnings

Vamousse Lice Prevention by is a Homeopathic medication manufactured, distributed, or labeled by TyraTech, Inc., Tropical Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Natrum muriaticum 1X (Sodium chloride, USP)

Purpose

Pediculosis remedy and prophylactic

Uses

For the prevention of head lice infestations

Warnings

For external use only

• Ask a doctor before use if you have infestation of eyebrows or eyelashes, or if you are pregnant.

• When using this product:
  do not use in or near the eyes, close eyes while product is being applied.
  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 skin irritation or infection is present or develops.

• Keep out of reach of children.
  
  
• If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if eye irritation occurs, skin or scalp irritation continues or infection occurs – Children under 6 months: ask a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Important: Read Warnings before use. Adults and children 6 months and over:

• Apply a generous amount of shampoo to wet hair, work into a lather and massage into scalp. Rinse thoroughly.
• Repeat process and leave shampoo on hair for at least 3 minutes.
• To treat head lice infestation, use the shampoo daily for at least 2 weeks.
• For best results on an extreme head lice infestation, use Vamousse treatment before using shampoo.

Product may be used as often as needed.

Other Information

Store between 59-86°F (15-30°C)

Inactive Ingredients

Benzyl alcohol, Cocomidopropyl betaine, Caprylic / capric triglycerides, Coconut oil, Disodium EDTA, Fragrances, Purified Water, Sodium laureth sulfate, Tea tree oil.

Questions?

1.855.373.7210 or www.VamousseLice.com

SPL UNCLASSIFIED SECTION

Manufactured By:
TYRATECH
5151 McCrimmon Parkway, Suite 275
Morrisville, NC 27560

PRINCIPAL DISPLAY PANEL - 236 ML Bottle Carton

DAILY SHAMPOO APPLICATION

NDC: 58962-003-01
HOMEOPATHIC

PREVENTS
LICE INFESTATION
IN 1 EASY STEP!
 

• HELPS KEEP YOUR FAMILY LICE FREE
• NON-TOXIC

VAMOUSSE™

LICE PREVENTION
SCIENTIFICALLY PROVEN SAFE & EFFECTIVE

8 FL OZ (236 ML)
GENTLE FOR DAILY USE

INGREDIENTS AND APPEARANCE

VAMOUSSE LICE PREVENTION 
sodium chloride shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58962-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37, chloride ion - UNII:Q32ZN48698)	SODIUM CHLORIDE	1 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GERANIOL (UNII: L837108USY)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58962-003-01	1 in 1 CARTON
1		236 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		01/16/2014

Labeler - TyraTech, Inc. (782845882)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Products, Inc.		157469086	MANUFACTURE(58962-003) , LABEL(58962-003)