VAMOUSSE PRO LICE TREATMENT- sodium chloride liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Natrum muriaticum 2X (HPUS)
Available from:
Tyra Tech, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Homeopathic pediculicide Treats head lice
Authorization status:
unapproved homeopathic
Authorization number:
58962-010-01

VAMOUSSE PRO LICE TREATMENT- sodium chloride liquid

Tyra Tech, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Vamous s e

Pro Lice Treatment

Drug Facts

Active Ingredients

Natrum muriaticum 2X (HPUS)

Purpos e

Homeopathic pediculicide

Us es

Treats head lice

Warnings

For external use only

Do not use

near eyes

inside nose

mouth

vagina

eyebrows or eyelashes.

See a doctor if lice are present in these areas.

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.

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

occurs. If pregnant or breastfeeding, 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.

Separate hair into sections, working with 1 inch sections at a time following your normal combing

procedure.

Thoroughly saturate all hair and scalp as you work, massaging product into the hair generously. To

be effective, all lice and nits must come in contact with the product. Note: dilution may reduce

®

efficacy.

Use approximately 2 fl oz (2 – 3 pumps) of lotion for an average head of hair.

If product needs to be thinned for particular hair type, use a spray bottle to lightly spritz the hair

with water, allowing lotion to spread more easily.

Using a lice/nit comb, comb hair from as close to the scalp as possible to the end of the hair.

If hair dries during combing, apply more product or use a spray bottle to lightly spritz the hair with

water, rehydrating the lotion.

After combing, thoroughly recheck for lice/nits. Repeat combing if necessary.

Product may be used as often as needed. Children under 2 years old: ask a doctor.

Other Information

Store between 59-86°F (15 -30°C).

Inactive Ingredients

Benzyl alcohol, Butyl lactate, Cetearyl alcohol, Cetrimonium chloride, DMDM Hydantoin, Fragrance,

Isopropyl alcohol, Isopropyl myristate, Magnesium chloride, Magnesium nitrate,

Methylchloroisothiazolinone, Methylisothiazolinone, Peppermint oil, Triethyl citrate, Water

Ques tions ?

1.855.373.7210 or www.VamousseLice.com

PRINCIPAL DISPLAY PANEL - 946 ML Bottle Label

NDC 58962-010-01

VAMOUSSE

Pro

Non-toxic

Pes ticide-free

Facilitates combing for

lice and nit removal

Dehydrates lice AND

eggs with safe

ingredients

FOR LICE TREATMENT

PROFESSIONALS

HOMEOPATHIC

32 FL OZ (946 ML)

®

VAMOUSSE PRO LICE TREATMENT

sodium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 9 6 2-0 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 , SODIUM CATION

- UNII:LYR4M0 NH37)

SODIUM

CHLORIDE

2 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

BUTYL LACTATE (UNII: 0 UI6 3W8 14U)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETRIMO NIUM CHLO RIDE (UNII: UC9 PE9 5IBP)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

GERANIO L (UNII: L8 3710 8 USY)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

MAGNESIUM CHLO RIDE (UNII: 0 2F3473H9 O)

MAGNESIUM NITRATE (UNII: 77CBG3UN78 )

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

Tyra Tech, Inc.

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 9 6 2-0 10 -0 1 9 46 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED HOMEOPATHIC

0 9 /25/20 15

Labeler -

T yra T ech, Inc. (782845882)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Tro pical Pro ducts, Inc.

15746 9 0 8 6

MANUFACTURE(58 9 6 2-0 10 ) , LABEL(58 9 6 2-0 10 )

Revised: 9/2015

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