NDC 52000-106 Universal Ice Cold Analgesic

Menthol

NDC Product Code 52000-106

NDC 52000-106-01

Package Description: 237 mL in 1 TUBE

NDC Product Information

Universal Ice Cold Analgesic with NDC 52000-106 is a a human over the counter drug product labeled by Universal Distribution Center Llc. The generic name of Universal Ice Cold Analgesic is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Universal Distribution Center 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.

Universal Ice Cold Analgesic 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.

  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

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: Universal Distribution Center Llc
Labeler Code: 52000
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-01-2020 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.

Universal Ice Cold Analgesic Product Label Images

Universal Ice Cold Analgesic 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 Ingredients

Menthol 1.25%

Purpose

Topical Analgesic

Uses

  • Temporary relieves of minor aches and pains in muscles and joints associated witharthritissimple backachestrainsbruisessports injuriessprains

Warnings

  • For external use only
  • Do not use
  • With other topical pain relieverswith heating pads or heating devices

When Using This Product

  • Do not use in or near the eyesdo not apply to wounds or damaged skindo not bandage tightly

Stop Use And Ask Doctor If

  • Condition worsenssymptoms last more than 7 days or clean up and occur again within a few daysredness or irritation develops

If Pregnant Or Breast-Feeding,

  • Ask a health professional before use

Keep Out Of The Reach Of Children

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

Directions

  • Clean affected area before applying productsadults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily.

Inactive Ingredients

Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

* Please review the disclaimer below.