VAMOUSSE LICE TREATMENT COMPLETE KIT- sodium chloride and eucalyptus globulus leaf aerosol, foam

Vamousse Lice Treatment Complete Kit by

Drug Labeling and Warnings

Vamousse Lice Treatment Complete Kit by is a Homeopathic medication manufactured, distributed, or labeled by Alliance Pharma Inc., PLZ Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Natrum muriaticum 2X (HPUS)

PURPOSE

Purpose

Pediculicide

INDICATIONS & USAGE

Uses

Treats head lice infestation

WARNINGS

For external use only

DO NOT USE

Do Not Use inside nose, mouth, or vagina, on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

WHEN USING

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.

Do not puncture or incinerate, contents under pressure.

Do not smoke or use near open flame or heated surface.

Consider using gloves to apply the product if you have sensitive skin as prolonged contact may dry your skin.

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Directions Important: Read ALL instructions on pamphlet inside box.Do not use on pets or to treat pubic or body lice. Adults and children 2 years and older: Treat to kill lice and eggs (nits): Start off with DRY hair. Separate hair into 3-4 sections with clips. Shake can well. Part a section of hair into a 1-inch section, focus the nozzle tip on the scalp and apply a generous amount of mousse along the length of the hair. Pay special attention to nape of neck and behind ears. Saturate all hair and scalp, massaging the mousse to break down the foam, thoroughly soaking the hair. To be effective all lice and nits must be contacted. Depending on length of hair, the full can may be needed. Repeat process until all sections of hair are saturated and wait 15 minutes. Remove lice and eggs (nits): Although dead, nits remain attached to the hair. After 15-minute treatment, use enclosed comb, to remove dead lice and nits from wet hair. Working with a 1-inch section of hair, insert the comb against the scalp, and pull through to the end, wiping on a disposable paper towel after each stroke. If hair dries during combing, apply more product to ease combing. Repeat combing if necessary. Shampoo and towel dry hair. Vamousse may be repeated as needed. Children under 2 years: ask a doctor.

Other Information

Other Information Do not store at temperature above 120°F (49°C). See package insert for additional information.

INACTIVE INGREDIENT

Inactive Ingredients Ammonium benzoate, Benzyl alcohol, Butyl lactate, Cocomidopropyl betaine, Fragrance, Isopropyl alcohol, Isopropyl myristate, Propellant A-46, Sodium lauryl sulfate, Triethyl citrate, Water

QUESTIONS

Questions? 1.855.373.7210 or www.VamousseLice.com. Call to report serious side effects.

Additional Label Content

VAMOUSSE

1. TREAT

Mousse kills lice AND eggs by dehydration

Kills Pesticide-Resistant Super Lice

Pesticide-free

Smells Great

Easy Mousse Application

Rinses our easily

Safe for children 2+

HOW TO USE:

Treat - Saturate Hair, Wait 15 Minutes

Working in small sections, apply and massage

mousse into DRY hair, to thoroughly saturate all hair and scalp.

Wait 15 minutes.

To be effective, lice and eggs must be contacted with Vamousse Lice Treatment.

One can designed to saturate hair and effectively treat 1 individual.

Depending on length and thickness of hair, you may need more than1 can to ensure complete saturation.

Comb

Remove dead lioce and eggs using the enclosed comb.

See insert for full details.

VAMOUSSE

2. DEFEND

Get ongoing control with this daily shampoo that kills lice contracted

from re-exposure or missed during treatment.

Lills lice, including super lice, as shown in lab studies.

Pesticide-free

No additional step, simply replace your daily shampoo

HOW TO USE:

Daily After Treatment

Use in place of regular shampoo for 10 - 14 days after treatment.

Shampoo is designed to kill lice with each use.

Family at Risk?

Look for full-size Vamousse Lice Defense Shampoo

for the whole family to use following lice exposure.

Made in the U.S,A.

Vamousse, Alliance and associated devices are trademarks of Alliance Pharmaceuticals Limited

Manufactured for

ALLIANCE

Alliance Pharma, Inc.

Cary, NC 27511

VamousseLice.com

PRINCIPAL DISPLAY PANEL

NDC: 72238-003-01

Pesticide-Free

LICE TREATMENT

CLINICALLY PROVEN

KILLS SUPER LICE & EGGS

ONCE AND DONE!

EASY TO USE MOUSSE

VAMOUSSE

HOMEOPATHIC

6 FL OZ (177 ML) & 1 COMB

INGREDIENTS AND APPEARANCE

VAMOUSSE LICE TREATMENT COMPLETE KIT 
sodium chloride and eucalyptus globulus leaf aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72238-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
VANILLIN (UNII: CHI530446X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BUTYL LACTATE (UNII: 0UI63W814U)
GERANIOL (UNII: L837108USY)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
AMMONIUM BENZOATE (UNII: AC80WD7GPF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72238-003-01	2 in 1 BOX	08/23/2019
1		177 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/23/2019

Labeler - Alliance Pharma Inc. (081138954)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmasol Corporation		065144289	label(72238-003) , pack(72238-003) , manufacture(72238-003)