NDC 72238-002 Vamousse Lice Defense

Pediculicide

NDC Product Code 72238-002

NDC 72238-002-01

Package Description: 295 mL in 1 BOTTLE, PLASTIC

NDC 72238-002-02

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Vamousse Lice Defense with NDC 72238-002 is a a human over the counter drug product labeled by Alliance Pharma Inc.. The generic name of Vamousse Lice Defense is pediculicide. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Alliance Pharma Inc.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Vamousse Lice Defense Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • EUCALYPTUS GLOBULUS LEAF 2 [hp_X]/mL
  • SODIUM CHLORIDE 2 [hp_X]/mL
  • EUCALYPTUS GLOBULUS LEAF 2 [hp_X]/mL
  • SODIUM CHLORIDE 2 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • MENTHYL ACETATE, (-)- (UNII: W8C5F4H1OA)
  • OCTYL ACETATE (UNII: X0FN2J413S)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARVONE, (-)- (UNII: 5TO7X34D3D)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • MENTHONE, (+/-)- (UNII: 9NH5J4V8FN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CITRAL (UNII: T7EU0O9VPP)
  • LEMON OIL (UNII: I9GRO824LL)
  • GERANYL ACETATE (UNII: 3W81YG7P9R)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • PENNYROYAL OIL (UNII: AK85U7Y3MV)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • WATER (UNII: 059QF0KO0R)
  • DECANAL (UNII: 31Z90Q7KQJ)
  • CARYOPHYLLENE (UNII: BHW853AU9H)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • LINALYL ACETATE, (+)- (UNII: 3ID3M89AV9)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • BUTYL LACTATE (UNII: 0UI63W814U)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • .ALPHA.-TERPINEOL (UNII: 21334LVV8W)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alliance Pharma Inc.
Labeler Code: 72238
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-02-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Vamousse Lice Defense Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Facts-Active Ingredients

Eucalyptus globulus 2X (HPUS)Natrum muriaticum 2X (HPUS)

Purpose

Pediculicide

Uses

For daily defense against head lice infestations.

Warnings

For external use only.

Do not use • near eyes • inside nose or mouth• on eyebrows or eyelashes. See a doctor if lice arepresent in these areas. Do not use if you have ever had anallergic reaction to this product or any of its ingredients.

When using this product:• Do not use in or near the eyes. Close eyes while applying.• Do not permit contact with mucous membranes, such asinside the nose, as irritation or stinging may occur.

Stop use and ask a doctor • if eye irritation occurs• skin or scalp irritation or infection occurs.

If pregnant or breast-feeding, ask a healthprofessional before use.

Children's Warning

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

Directions

Directions:Adults and children 2 years and older:• Apply a generous amount of shampoo to wet hair, workinto a lather and massage into scalp. Leave shampoo inhair for at least 3 minutes. Rinse.• For defense against a head lice infestation, use daily for atleast 10 to 14 days to kill any lice that may have hatched.• For an active head lice infestation, use Vamousse® LiceTreatment before using this shampoo.Children under 2 years: ask a doctor.Product may be used as often as needed.

Inactive Ingredients

Inactive Ingredients Benzyl alcohol, Butyl lactate,Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropylmyristate, Sodium chloride, Sodium lauryl s sulfate, Water

Questions?

Questions? 1.855.373.7210 or www.VamousseLice.comCall to report serious side effects

Additionl Label Content

Manufactured For:Alliance Pharma Inc., Cary, NC 27511Made in the U.S.A. Vamousse, Alliance and associated devices are trademarks of Alliance Pharmaceuticals Limited

Vamousse Lice Prevention Shampoo 295 Ml Bottle

SUPER LICE DEFENSENDC 72238-002-01DAILY DEFENSE AGAINST LICELICE DEFENSEVAMOUSSE®GENTLE SHAMPOOKills Lice*Safe, Non-ToxicPesticide-Free100%SatisfactionGuaranteedFor use by the whole family duringSchool outbreaksSummer camp, sleepoversTreatment of a sibling100% Satisfaction Guaranteed*as shown in lab studiesHOMEOPATHIC10 FL OZ (295 ml)Drug FactsActive Ingredients PurposeEucalyptus globulus 2X (HPUS) PediculicideNatrum muriaticum 2X (HPUS) PediculicideUses: For daily defense against head lice infestations.WarningsFor external use only.Do not use • near eyes • inside nose or mouth• on eyebrows or eyelashes. See a doctor if lice arepresent in these areas. Do not use if you have ever had anallergic reaction to this product or any of its ingredients.When using this product:• Do not use in or near the eyes. Close eyes while applying.• Do not permit contact with mucous membranes, such asinside the nose, as irritation or stinging may occur.Stop use and ask a doctor • if eye irritation occurs• skin or scalp irritation or infection occurs.If pregnant or breast-feeding, ask a healthprofessional before use.Keep out of reach of children. If swallowed, getmedical help or contact a Poison Control Center right away.Directions:Adults and children 2 years and older:• Apply a generous amount of shampoo to wet hair, workinto a lather and massage into scalp. Leave shampoo inhair for at least 3 minutes. Rinse.• For defense against a head lice infestation, use daily for atleast 10 to 14 days to kill any lice that may have hatched.• For an active head lice infestation, use Vamousse® LiceTreatment before using this shampoo.Children under 2 years: ask a doctor.Product may be used as often as needed.Inactive Ingredients Benzyl alcohol, Butyl lactate,Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropylmyristate, Sodium chloride, Sodium lauryl s sulfate, WaterQuestions? 1.855.373.7210 or www.VamousseLice.comCall to report serious side effectsManufactured For:Alliance Pharma Inc., Cary, NC 27511Made in the U.S.A. Vamousse, Alliance and associated devices are trademarks of Alliance Pharmaceuticals Limited

* Please review the disclaimer below.