Vamousse Lice Prevention
FDA Label NDC 58962-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tyratech, Inc. for the product Vamousse Lice Prevention (NDC 58962-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - ask doctor, otc - when using, otc - ask doctor/pharmacist, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Natrum muriaticum 1X (Sodium chloride, USP)

Purpose

Pediculosis remedy and prophylactic

Uses

For the prevention of head lice infestations

Warnings

For external use only

Otc - Ask Doctor

  • Ask a doctor before use if you have infestation of eyebrows or eyelashes, or if you are pregnant.

Otc - When Using

  • When using this product:
    do not use in or near the eyes, close eyes while product is being applied.
    do not permit contact with mucous membranes, such as inside the nose as irritation or stinging may occur.

Otc - Ask Doctor/Pharmacist

  • Stop use and ask a doctor if skin irritation or infection is present or develops.

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.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if eye irritation occurs, skin or scalp irritation continues or infection occurs – Children under 6 months: ask a doctor.

Directions

Important: Read Warnings before use. Adults and children 6 months and over:

  • Apply a generous amount of shampoo to wet hair, work into a lather and massage into scalp. Rinse thoroughly.
  • Repeat process and leave shampoo on hair for at least 3 minutes.
  • To treat head lice infestation, use the shampoo daily for at least 2 weeks.
  • For best results on an extreme head lice infestation, use Vamousse treatment before using shampoo.

    • Product may be used as often as needed.

Other Information

Store between 59-86°F (15-30°C)

Inactive Ingredients

Benzyl alcohol, Cocomidopropyl betaine, Caprylic / capric triglycerides, Coconut oil, Disodium EDTA, Fragrances, Purified Water, Sodium laureth sulfate, Tea tree oil.

Questions?

1.855.373.7210 or www.VamousseLice.com

Other

Manufactured By:
TYRATECH
5151 McCrimmon Parkway, Suite 275
Morrisville, NC 27560

Principal Display Panel - 236 Ml Bottle Carton

DAILY SHAMPOO APPLICATION

NDC 58962-003-01
HOMEOPATHIC

PREVENTS
LICE INFESTATION
IN 1 EASY STEP!
 

  • HELPS KEEP YOUR FAMILY LICE FREE
  • NON-TOXIC

    • VAMOUSSE™

    LICE PREVENTION
    SCIENTIFICALLY PROVEN SAFE & EFFECTIVE

    8 FL OZ (236 ML)
    GENTLE FOR DAILY USE

    Principal Display Panel (236 ML Bottle Carton)

    Principal Display Panel (236 ML Bottle Carton)

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