NDC 72591-0754 Cbd Unlimited Balmx

Menthol, Camphor

NDC Product Code 72591-0754

NDC 72591-0754-2

Package Description: 60 mL in 1 JAR

NDC Product Information

Cbd Unlimited Balmx with NDC 72591-0754 is a a human over the counter drug product labeled by Velocity Production And Packaging. The generic name of Cbd Unlimited Balmx is menthol, camphor. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Velocity Production And Packaging

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.

Cbd Unlimited Balmx 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 1.25 g/100mL

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.

  • ARNICA MONTANA (UNII: O80TY208ZW)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CLOVE (UNII: K48IKT5321)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • HEMP (UNII: TD1MUT01Q7)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
  • MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)

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: Velocity Production And Packaging
Labeler Code: 72591
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: 12-16-2020 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.

Cbd Unlimited Balmx Product Label Images

Cbd Unlimited Balmx 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(S)

MENTHOL USP 1.25%

Purpose

TOPICAL ANALGESIC

Uses

  • TEMPORARY RELIEF FROM MINOR ACHES AND PAINS OF MUSCLES & JOINTS ASSOCIATED WITH:ARTHRITISSIMPLE BACKACHESTRAINSSPRAINS

Warnings

  • FOR EXTERNAL USE ONLY.DO NOT USE ON WOUNDS OR DAMAGED SKIN.WHEN USING THIS PRODUCT:AVOID CONTACT WITH THE EYESDO NOT BANDAGE TIGHTLYSTOP USE AND ASK A DOCTOR IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.IF PREGNANT OR BREAT-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • ADULTS AND CHILDREN 12 YEARS OF AGE & OLDER. RUB WELL ON AFFECTED AREAS NOT MORE THAN 3 TO 4 TIMES DAILY.FOR CHILDREN 12 YEARS OR YOUNGER, CONSULT A DOCTOR BEFORE USE.

Other Information

THIS PRODUCT MAY CAUSE AN ALLERGIC REACTION FOR SOME INDIVIDUALS. TEST ON SMALL AREA BEFORE USE.

Inactive Ingredients

ARNICA OIL, BEESWAX, CLOVE BUD OIL, GRAPESEED OIL, HEMP ISOLATE, HEMP SEED OIL, LAVENDER OIL, METHYLSULFONYLMETHANE (MSM), MCT COCONUT OIL, ORGANIC LEMONGRASS OIL, ORGANIC MORINGA OIL, SWEET BIRCH OIL.

* Please review the disclaimer below.