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., Accupac, LLC. 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 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.

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.

For defense against a 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.

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

Manufactured For:

Alliance Pharma Inc., Cary, NC 27511

Made in the U.S.A. Vamousse, Alliance and associated devices are trade

marks of Alliance Pharmaceuticals Limited

VAMOUSSE LICE PREVENTION SHAMPOO 295 ML Bottle

SUPER LICE DEFENSE

NDC: 72238-002-01

DAILY DEFENSE AGAINST LICE

LICE DEFENSE

VAMOUSSE®

GENTLE SHAMPOO

Kills Lice*

Safe, Non-Toxic

Pesticide-Free

100%

Satisfaction

Guaranteed

For use by the whole family during

School outbreaks

Summer camp, sleepovers

Treatment of a sibling

100% Satisfaction Guaranteed

*as shown in lab studies

HOMEOPATHIC

10 FL OZ (295 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 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.

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.

For defense against a 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.

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

Manufactured For:

Alliance Pharma Inc., Cary, NC 27511

Made in the U.S.A. Vamousse, Alliance and associated devices are trade

marks of Alliance Pharmaceuticals Limited

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)
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)
PENNYROYAL OIL (UNII: AK85U7Y3MV)
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: 72238-002-01	295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/02/2018

Labeler - Alliance Pharma Inc. (081138954)

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