NDC 72670-001 Lilas Feminine Pain Relief Patch

Menthol

NDC Product Code 72670-001

NDC Code: 72670-001

Proprietary Name: Lilas Feminine Pain Relief Patch What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72670 - Radee Health Ventures Private Limited
    • 72670-001 - Lilas Feminine Pain Relief Patch

NDC 72670-001-05

Package Description: 5 POUCH in 1 PACKAGE > 1 PATCH in 1 POUCH

NDC 72670-001-10

Package Description: 10 POUCH in 1 BOX > 1 PATCH in 1 POUCH

NDC Product Information

Lilas Feminine Pain Relief Patch with NDC 72670-001 is a a human over the counter drug product labeled by Radee Health Ventures Private Limited. The generic name of Lilas Feminine Pain Relief Patch is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Radee Health Ventures Private Limited

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Lilas Feminine Pain Relief Patch 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.

  • MENTHOL, UNSPECIFIED FORM 200 mg/1

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.

  • EUCALYPTUS OIL (UNII: 2R04ONI662)

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.

Product Labeler Information

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

Labeler Name: Radee Health Ventures Private Limited
Labeler Code: 72670
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-18-2019 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: 12-31-2020 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.

Lilas Feminine Pain Relief Patch Product Label Images

Lilas Feminine Pain Relief Patch 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 (In Each Patch)

Menthol 10.0%

Otc - Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains associated with:•menstrual cramps •lower pelvic pain •backache •leg cramps •sprains •strains

Warnings

For external use only            Use only as directedDo not use• on wounds or damaged skin            • with a heating padAsk a doctor before use if you have • redness over affected areaWhen using this product• avoid contact with the eyes, mucous membranes and rashes            • do not bandage tightlyStop use or ask a doctor if• condition worsens or symptoms persists for more than 7 days or clear up and occur again within a few days• abnormal skin irritation occurs after usage

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 12 years of age and older apply to the affected area no more than 2 times dailydry the skin at application area before applying the patchopen pouch & remove patchpeel of protective film and apply sticky side to affected areachildren under 12 years of age consult a doctor

Other Information

Store at room temperature below 80°F (27ºC)

Inactive Ingredients

• adhesive plaster  • eucalyptus oil

Questions?

Call 1-833-400-4102

* Please review the disclaimer below.

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