VAMOUSSE LICE DEFENSE- pediculicide shampoo

Vamousse Lice Defense by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS-Active Ingredients

Eucalyptus globulus 2X (HPUS)

Natrum muriaticum 2X (HPUS)

Purpose

Pediculicide

Uses

For daily defense against head lice infestations.

Warnings

For external use only.

Warnings

Do not use near eyes inside nose, mouth, or vagina

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.

Warnings

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.

Warnings

Stop use and ask a doctor if eye irritation occurs

skin or scalp irritation or infection occurs.

Warnings

If pregnant or breast-feeding, ask a health

professional before use.

Children's Warning

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center right away.

Directions

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.

Use daily for at least 10 - 14 days following treatment, during risk of re-infestation.

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

Inactive Ingredients Benzyl alcohol, Butyl lactate,

Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl

myristate, Sodium chloride, Sodium lauryl s sulfate, Water

Questions?

Questions? 1.855.373.7210 or www.VamousseLice.com

Call to report serious side effects

Additionl Label Content

Vamousse, Alliance and associated devices are trade

marks of Alliance Pharmaceuticals Limited

Manufactured For:

Alliance Pharma Inc., Cary, NC 27511

VAMOUSSE LICE DEFENSE SHAMPOO 118 ML Bottle

SUPER LICE DEFENSE

NDC: 72238-002-02

DAILY DEFENSE AGAINST LICE

LICE DEFENSE

VAMOUSSE®

HOMEOPATHIC

GENTLE SHAMPOO

Kills Lice*

for treatment follow-up

Safe, Non-Toxic

when used as directed

Pesticide-Free

*as shown in lab studies

4 FL OZ (118 ml)

Drug Facts

Active Ingredients Purpose

Eucalyptus globulus 2X (HPUS) Pediculicide

Natrum muriaticum 2X (HPUS) Pediculicide

Uses: For daily defense against head lice infestations.

Warnings

For external use only.

Do not use near eyes inside nose, mouth, or vagina

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.

Use daily for at least 10 - 14 days following treatment, during risk of re-infestation.

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 Benzyl alcohol, Butyl lactate,

Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl

myristate, Sodium chloride, Sodium lauryl s sulfate, Water

Questions? 1.855.373.7210 or www.VamousseLice.com

Call to report serious side effects

Vamousse, Alliance and associated devices are trade

marks of Alliance Pharmaceuticals Limited

Manufactured For:

Alliance Pharma Inc., Cary, NC 27511

INGREDIENTS AND APPEARANCE

VAMOUSSE LICE DEFENSE 
pediculicide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72238-002
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) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	2 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT (UNII: V95R5KMY2B)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
MENTHYL ACETATE, (-)- (UNII: W8C5F4H1OA)
OCTYL ACETATE (UNII: X0FN2J413S)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PENNYROYAL OIL (UNII: AK85U7Y3MV)
CARVONE, (-)- (UNII: 5TO7X34D3D)
ORANGE OIL (UNII: AKN3KSD11B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
MENTHONE, (+/-)- (UNII: 9NH5J4V8FN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CITRAL (UNII: T7EU0O9VPP)
LEMON OIL (UNII: I9GRO824LL)
GERANYL ACETATE (UNII: 3W81YG7P9R)
SPEARMINT OIL (UNII: C3M81465G5)
LEVOMENTHOL (UNII: BZ1R15MTK7)
WATER (UNII: 059QF0KO0R)
DECANAL (UNII: 31Z90Q7KQJ)
CARYOPHYLLENE (UNII: BHW853AU9H)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LINALYL ACETATE, (+)- (UNII: 3ID3M89AV9)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYL LACTATE (UNII: 0UI63W814U)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-TERPINEOL (UNII: 21334LVV8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72238-002-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/21/2019

Labeler - Alliance Pharma Inc. (081138954)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmasol Corporation		065144289	manufacture(72238-002) , label(72238-002) , pack(72238-002)