VAMOUSSE PRO TOTAL LICE EMERGENCY KIT- pediculicide kit

Vamousse Pro Total Lice Emergency Kit by

Drug Labeling and Warnings

Vamousse Pro Total Lice Emergency Kit by is a Homeopathic medication manufactured, distributed, or labeled by Alliance Pharma Inc., Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Vamousse Lice Treatment:

Natrum Muriaticum 2X (HPUS)

Vamousse Lice Defense Daily Shampoo:

Eucalyptus globulus 2X (HPUS)

Natrum Muriaticum 2X (HPUS)

PURPOSE

Purpose

Pediculicide

INDICATIONS & USAGE

Vamousse Lice Treatment:

Treats head lice infestation

Vamousse Lice Defense Daily Shampoo:

For daily defense against head lice infestations

WARNINGS

For external use only

Vamouss Lice Treatment:

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

Vamousse Lice Defense Daily Shampoo:

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.

Vamousse Lice Treatment
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.

Vamousse Lice Defense Daily Shampoo:

When using this product Do not use 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 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.

DOSAGE & ADMINISTRATION

Vamousse Lice Treatment:

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 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 the neck and behind the 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 the 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 the 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, 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.

Vamousse Lice Defense Daily Shampoo:

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 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.

OTHER SAFETY INFORMATION

INACTIVE INGREDIENT

Vamousse Lice Treatment

Inactive Ingredients

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

Vamousse Lice Defense Daily Shampoo:

Inactive Ingredients

Benzyl alcohol, Butyl lactate, Cocomidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl myristate, Sodium Chloride, Sodium lauryl sulfate, Water

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VAMOUSSE PRO TOTAL LICE EMERGENCY KIT 
pediculicide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72238-005

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72238-005-01	1 in 1 BOX; Type 0: Not a Combination Product	05/10/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, WITH APPLICATOR	177 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

VAMOUSSE LICE TREATMENT 
pediculicide aerosol, foam

Product Information
Item Code (Source)	NDC: 72238-001
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
BUTYL LACTATE (UNII: 0UI63W814U)
GERANIOL (UNII: L837108USY)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)
AMMONIUM BENZOATE (UNII: AC80WD7GPF)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		177 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/01/2018

Part 2 of 2

VAMOUSSE LICE DEFENSE 
eucalyptus globulus, natrum muriaticum shampoo

Product Information
Item Code (Source)	NDC: 72238-004
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
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GERANIOL (UNII: L837108USY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
EUCALYPTUS OIL (UNII: 2R04ONI662)
POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)
EDETATE SODIUM (UNII: MP1J8420LU)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TEA TREE OIL (UNII: VIF565UC2G)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYL LACTATE (UNII: 0UI63W814U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 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		05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/10/2023

Labeler - Alliance Pharma Inc. (081138954)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	manufacture(72238-005) , pack(72238-005)