NDC 73668-001 Tjz Night-time Topical Pain Relief Balm

Menthol

NDC Product Code 73668-001

NDC 73668-001-01

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 14 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Tjz Night-time Topical Pain Relief Balm with NDC 73668-001 is a a human over the counter drug product labeled by Lab-o Corp. The generic name of Tjz Night-time Topical Pain Relief Balm is menthol. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Lab-o Corp

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Tjz Night-time Topical Pain Relief Balm 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 24 mg/g

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.

  • JOJOBA OIL (UNII: 724GKU717M)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • GINGER OIL (UNII: SAS9Z1SVUK)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)

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: Lab-o Corp
Labeler Code: 73668
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: 09-27-2020 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.

Tjz Night-time Topical Pain Relief Balm Product Label Images

Tjz Night-time Topical Pain Relief Balm 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

Natural Menthol USP 2.4%

Purpose

Topical analgesic

Uses

The temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use onlyAllergy alert: If you are allergic to aspirin or salicylates, consult a doctor before use

When Using This Product

  • Use only as directedavoid contact with eyes and mucous membraneswash hands with soap and water after usedo not apply to wounds, or damaged skindo not cover with bandage or apply heat

Stop Use And Ask A Doctor If

  • Condition worsensredness or skin irritation occurssymptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast-Feeding

Or if you have sensitive skin, ask a healthcare professional before use

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Flammable

Keep away from excessive heat or open flame

Directions

For adults and children over 12, using the applicator tip, massage into affected area before bedtime.
For children 12 years of age or younger, consult a physician before use.

Inactive Ingredients

Jojoba Seed Oil*, Beeswax*, Wintergreen Leaf Oil*, Lavender Oil*, Ginger Root Oil*, Camphor*Organic

Other Information

Store in a cool, dry place, away from heat with lid closed tightly. Contains natural methyl salicylate from wintergreen. Report serious adverse reactions to: TJz Balm PO Box 1778, Boca Raton, FL 33429-1778 USACertified Organic by PCO

Company Information

TJzbalm.comQuestions: support@tjzbalm.com

Product Packaging

TJz balmNight-time Topical pain relief balmMoisturizing andSoothingFor Jaw, Neck & Behind EarsHands-free, Massaging tip applicatorA portion of the profitswill be donated to TMJ Research0.5 oz (14 g)

* Please review the disclaimer below.