FDA Label for Vamousse Lice Treatment Complete Kit
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- ADDITIONAL LABEL CONTENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Vamousse Lice Treatment Complete Kit Product Label
The following document was submitted to the FDA by the labeler of this product Alliance Pharma Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient
Natrum muriaticum 2X (HPUS)
Otc - Purpose
Purpose
Pediculicide
Indications & Usage
Uses
Treats head lice infestation
Warnings
For external use only
Otc - 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.
Otc - 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.
Otc - Stop Use
Stop use and ask a doctor if eye irritation occurs, skin or scalp irritation continues or infection occurs.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - 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
Otc - 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
Package Label.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
* Please review the disclaimer below.