Herbal Balm

Methyl Salicylate, Menthol And

Big 5 Nutrition Llc
Human Otc Drug
NDC 82198-0007

Herbal Balm also known as Methyl Salicylate, Menthol And is a human otc drug labeled by 'Big 5 Nutrition Llc'. National Drug Code (NDC) number for Herbal Balm is 82198-0007. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Herbal Balm drug includes Camphor (synthetic) - 31 mg/g Menthol - 156 mg/g Methyl Salicylate - 207 mg/g . The currest status of Herbal Balm drug is Active.

Drug Information:

Drug NDC:	82198-0007
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Herbal Balm
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Methyl Salicylate, Menthol And
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Big 5 Nutrition Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CAMPHOR (SYNTHETIC) - 31 mg/g MENTHOL - 156 mg/g METHYL SALICYLATE - 207 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 Oct, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	14 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part348
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Big 5 Nutrition LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	5TJD82A1ET L7T10EIP3A LAV5U5022Y
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
82198-0007-1	50 g in 1 JAR (82198-0007-1)	01 Oct, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Herbal Balm

Methyl Salicylate, Menthol And

Cream
Big 5 Nutrition LLC
NDC: 82198-0007

Purpose:

Purpose external analgesic

Product Elements:

Herbal balm methyl salicylate, menthol and eucalyptus oil lavender oil petrolatum white wax menthol menthol methyl salicylate salicylic acid camphor (synthetic) camphor (synthetic)

Indications and Usage:

Uses for temporary relief of minor aches and pains of muscles and joints due to: arthritis strains bruises sprains simple backache

Warnings:

Warnings for external use only do not use on wounds irritated or damaged skin sensative skin with a heating pad if pregnant with, or as the same time as, other external analgesic products if allergic to aspirin or salicylates if allergic to any ingredients of this prodcut when using this product avoid contact with eyes do not bandage tightly do not apply to wounds or damaged skin do not use 1 hour before or after bathing stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritation of the skin develops redness is present side effects occur if pregnant , ask a health professional before use. keep out of reach of children to avoid accidental poisoning in case of overdose , get medical help or contact a poison control center right away. do not use otherwise than as directed.

Do Not Use:

When Using:

When using this product avoid contact with eyes do not bandage tightly do not apply to wounds or damaged skin do not use 1 hour before or after bathing

Dosage and Administration:

Directions apply to the affected area. rub well on affected area. repeat 2 times daily. children under 2 years of age: do not use or consult a doctor.

Stop Use:

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritation of the skin develops redness is present side effects occur

Package Label Principal Display Panel:

Principal display panel label

Further Questions:

Questions or comments? tel: 714-531-2020 web: tnduocthao.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.