NDC 71402-101 The Relief Company

Menthol

NDC Product Code 71402-101

NDC 71402-101-01

Package Description: 89 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

The Relief Company with NDC 71402-101 is a a human over the counter drug product labeled by Symedic Llc. The generic name of The Relief Company is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Symedic Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

The Relief Company 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 g/100mL

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: Symedic Llc
Labeler Code: 71402
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: 09-03-2019 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.

The Relief Company Product Label Images

The Relief Company 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 Ingredient

Menthol 2%

Purpose

Topical analgesic

Use

  • Temporary relief from minor aches and pains of sore muscles & joints associated witharthritissimple backachestrainsbruisessprains.

Warnings

For external use only.

Otc - When Using

  • When using this productAvoid contact with the eye or mucous membranesDo not apply to wounds or damaged skinDo not use with other ointments, creams, sprays or linimentsDo not apply to irritated skin or if excessive irritation developsDo not bandageWash hands after use with cool waterDo not use with heating pad or deviceContains sulfur compounds.

Otc - Stop Use

Stop use and ask a doctor if conditions worsen, or if symptoms persist for more than 7 days, or clear up and reoccur.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and older: Spray onto affected areas no more than 4 times daily; massage not necessary. Children under 12 years of age: consult a physician.

Other Information

Store in a cool dry place with lid closed tightly.

Inactive Ingredients

Dimethyl sulfone, dimethyl sulfoxide, eucalyptus oil*, hydrogen peroxide, peppermint oil*, spike lavender oil*, water.

Relleve Naturals - Menthol Spray [​7140288801]

  • New7140288801Relleve NaturalsDeep Penetrating Pain ReliefAll-Natural FormulaEssential Oil BlendFor Muscle & Joint PainTopical Spray1 fl oz / 30 ml

* Please review the disclaimer below.