FDA.reportPublic FDA data

Vamousse Lice Protection

Manufacturer
TyraTech, Inc. | Tropical Products, Inc.
Effective date
2015-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:47

Label at a glance#

ProductVamousse Lice Protection
Active ingredientEUCALYPTUS GLOBULUS LEAF, SODIUM CHLORIDE
Label structure9 sections

Indications and uses

For protection against head lice infestations.

Dosage and administration

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 protection 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 ...

Storage and handling

Store between 59-86°F (15 -30°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients:Purpose:
Eucalyptus globulus 2X (HPUS)Head lice preventer
Natrum muriaticum 2X (HPUS)Pediculicide

Uses

INDICATIONS & USAGE SECTION

For protection against head lice infestations.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • near eyes
  • inside nose or mouth
  • on eyebrows or eyelashes. See a doctor if lice are present in these areas.

OTC - WHEN USING SECTION

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.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if eye irritation occurs
  • skin or scalp irritation or infection occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If pregnant or breast-feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 protection 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.

Other Information

STORAGE AND HANDLING SECTION

Store between 59-86°F (15 -30°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, Butyl lactate, Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl myristate, Magnesium lauryl sulfate, Sodium chloride, Water

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GENTLE DAILY SHAMPOO

NDC 58962-004-01
PESTICIDE-FREE

100% EFFECTIVE*
PROTECTION
AGAINST HEAD LICE

VAMOUSSE®

  • KILLS LICE BEFORE YOU
    KNOW THEY ARE THERE
  • HELPS KEEP YOUR
    FAMILY LICE FREE
  • SAFE, NON-TOXIC

LICE
PROTECTION

SATISFACTION
100%
GUARANTEED

8 FL OZ (236 ML)
HOMEOPATHIC

19160FRT2014338

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58962-004-012020-01-31C16284748780-19d75b9d1-20bb-f424-e053-dadaa90a57ceVamousse ® Lice Protection Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58962-004-01Vamousse Lice Protection236 mL in 1 BOTTLE, PLASTICSHAMPOO2361
58962-004-01Vamousse Lice Protection1 in 1 CARTONSHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58962-004VAMOUSSE LICE PROTECTION (EUCALYPTUS GLOBULUS LEAF AND SODIUM CHLORIDE) SHAMPOO [TYRATECH, INC.]1Legacy NDC, 2 package rows20160429_084e1f03-3ce0-4663-b98b-74516ee9fc43.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58962-00458962-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS GLOBULUS LEAFS546YLW6E6ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
BENZYL ALCOHOLLKG8494WBHIACT
BUTYL LACTATE0UI63W814UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GERANIOLL837108USYIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MAGNESIUM LAURYL SULFATET88HA2N17XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c9ea6c90-048c-43ae-8ede-a7d541b612ec084e1f03-3ce0-4663-b98b-74516ee9fc432015-04-30WarningsExact identifier
spl id: c9ea6c90-048c-43ae-8ede-a7d541b612ec
spl set id: 084e1f03-3ce0-4663-b98b-74516ee9fc43

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.