Vamousse Pro Lice Treatment
FDA Label NDC 58962-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tyra Tech, Inc. for the product Vamousse Pro Lice Treatment (NDC 58962-010). 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 other, active ingredients, purpose, uses, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Natrum muriaticum 2X (HPUS)

Purpose

Homeopathic pediculicide

Uses

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.

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.

Otc - Stop Use

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.

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

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

Questions?

1.855.373.7210 or www.VamousseLice.com

Principal Display Panel - 946 Ml Bottle Label

NDC 58962-010-01

VAMOUSSE®

Pro

  • Non-toxic
  • Pesticide-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)

    Principal Display Panel (946 ML Bottle Label)

    Principal Display Panel (946 ML Bottle Label)

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