NDC 73576-001 Molleave

Lemon Balm Oil

NDC Product Code 73576-001

NDC 73576-001-00

Package Description: 1 TUBE in 1 BOX > 22 g in 1 TUBE (73576-001-01)

NDC Product Information

Molleave with NDC 73576-001 is a a human over the counter drug product labeled by Innovative Med. The generic name of Molleave is lemon balm oil. The product's dosage form is cream and is administered via topical form.

Labeler Name: Innovative Med

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Molleave 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.

  • LEMON BALM OIL 1 [hp_X]/22g

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.

  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)
  • CLOVE OIL (UNII: 578389D6D0)
  • CROTON LECHLERI RESIN (UNII: GGG6W25C63)
  • SORBIC ACID (UNII: X045WJ989B)
  • TEA TREE OIL (UNII: VIF565UC2G)

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: Innovative Med
Labeler Code: 73576
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: 02-05-2020 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: 12-31-2021 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.

Molleave Product Label Images

Molleave 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

Active Ingredients

Active Ingredient PurposeLemon balm oil 1x............................................MCV Relief

Purpose

PurposeMCV Relief

Use

  • Use Molluscum Contagiosum lesion relief.

Warnings

  • WarningsFor external use onlyDo not use on large areas of the body, wounds, punctured skin, in eyes, animal bites or burns.Stop use and ask doctor if rash or allergic reaction occurs/Condition worsens.If swallowed induce vomiting, get medical help or contact a Poison Control Center right away.

Keep Out Of Reach Of Children.

Keep out of reach of children.

Directions

  • DirectionsClean infected skin area.Apply small aount (equal to lesion size) on each lesion.Gently rub in circular motion leaving thin cream layer.Repeat treatment 2 to 3 times daily.Let dry for 3 minutes.

Other Information

  • Other InformationStore below 30 degrees C (86 degrees F)Do not freeze or refrigerateDiscard six months after openingMay stain fabrics and surfaces

Inactive Ingredients

Inactive Ingredients Caprylyl Glycol, Clove oil, Croton lechleri, Lemon grass oil, phenoxyethanol, sorbic acid, tea tree oil, thuja occidentalis

Inactive Ingredients Caprylyl Glycol, Clove oil, Croton lechleri, Lemon grass oil, phenoxyethanol, sorbic acid, tea tree oil, thuja occidentalis

* Please review the disclaimer below.