NDC 76348-620 From Earth Penetrating Menthol Pain Relief Roll On

Menthol Roll-on

NDC Product Code 76348-620

NDC CODE: 76348-620

Proprietary Name: From Earth Penetrating Menthol Pain Relief Roll On 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 Roll-on 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

  • 76348 - Renu Laboratories, Inc.
    • 76348-620 - From Earth Penetrating Menthol Pain Relief Roll On

NDC 76348-620-01

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 84 g in 1 BOTTLE, WITH APPLICATOR (76348-620-03)

NDC Product Information

From Earth Penetrating Menthol Pain Relief Roll On with NDC 76348-620 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of From Earth Penetrating Menthol Pain Relief Roll On is menthol roll-on. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Renu Laboratories, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

From Earth Penetrating Menthol Pain Relief Roll On 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 4.2 g/84g

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.

  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • GUAIOL (UNII: I7WP008A91)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • .GAMMA.-TERPINENE (UNII: 4YGF4PQP49)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • .ALPHA.-TERPINENE (UNII: I24X278AP1)
  • CARYOPHYLLENE (UNII: BHW853AU9H)
  • .BETA.-CARYOPHYLLENE OXIDE (UNII: S2XU9K448U)
  • .BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)
  • .BETA.-PINENE (UNII: 4MS8VHZ1HJ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • CANNABIGEROL (UNII: J1K406072N)
  • .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
  • HUMULENE (UNII: 54W56MD2WD)
  • .ALPHA.-PINENE (UNII: JPF3YI7O34)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MYRCENE (UNII: 3M39CZS25B)
  • WATER (UNII: 059QF0KO0R)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • P-CYMENE (UNII: 1G1C8T1N7Q)
  • TERPINOLENE (UNII: N9830X5KSL)
  • NEROLIDOL (UNII: QR6IP857S6)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

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: Renu Laboratories, Inc.
Labeler Code: 76348
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: 05-12-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

From Earth Penetrating Menthol Pain Relief Roll On Product Label Images

From Earth Penetrating Menthol Pain Relief Roll On 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

Otc - Active Ingredient

Active IngredientMenthol 5 percent

Purpose

Topical Analgesic

Indications & Usage

  • Uses for temporary relief of minor aches and pains of muscles and joints associated with
  • Bruisessprainsarthritisstrains

Warnings

For external use only

Otc - When Using

  • When using this productDo not bandage tightlyavoid contact with eyesdo not apply to wounds or damaged skindo not use with heating pads or other heating devices.

Otc - Stop Use

  • Stop use and ask a doctor ifCondition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsadults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for painchildren under 12 years of age: do not use, consult a doctor.

Inactive Ingredient

Inactive Ingredients:Arnica Montana (Arnica) Extract, Cannabidiol (CBD) Hemp-derived, Cannabigerol (CBG) Hemp-derived, Cannabis Sativa (Hemp) Seed Oil with a proprietary mix of terpenes (alpha-bisabolol, alpha-humulene, alpha-pinene, alpha-terpinene, beta-caryophyllene, beta-myrcene, beta-pinene, caryophyllene oxide, cis-beta-ocimene, D-limonene, eucalyptol, gamma-terpinene, guaiol, linalool, menthol, p-cymene, terpinolene, trans-nerolidol), Deionized Water, Fragrance, Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.

Otc - Questions

Questions? Comments?contact us at844 44-FE-CBD

Recent Major Changes

No changes made in the following sections:• Boxed Warning

• Indications and Usage

• Dosage and Administration

• Contraindications

• Warnings and Precautions

* Please review the disclaimer below.