NDC 55628-9107 Ultracin M

Menthol

NDC Product Code 55628-9107

NDC Product Information

Ultracin M with NDC 55628-9107 is a a human over the counter drug product labeled by Cal Pharma. The generic name of Ultracin M is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Cal Pharma

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.

Ultracin M 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 5 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.

  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
  • CITRUS LIMON WHOLE (UNII: EEI224A33Y)
  • ALCOHOL (UNII: 3K9958V90M)
  • GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
  • PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)
  • MARITIME PINE (UNII: 50JZ5Z98QY)
  • WILLOW BARK (UNII: S883J9JDYX)
  • ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
  • ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cal Pharma
Labeler Code: 55628
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: 01-24-2016 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’.

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Ultracin M Product Label Images

Ultracin M 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

Otc - Active Ingredient

MENTHOL (5%)

Otc - Purpose

TOPICAL ANALGESIC

Indications & Usage

USE- TEMPORARILY RELIEVES MILD ACHES, PAINS AND INFLAMMATION OF MUSCLE AND JOINTS ASSOCIATED WITH NERVE DAMAGE AND SPORT INJURIES.

Warnings

WARNINGSFOR EXTERNAL USE ONLYDO NOT USE ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS OR OTHER MUCOUS MEMBRANESTOP USE AND CONSULT YOUR PHYSICIAN IF PAIN IS PERSISTENT OR WORSENS

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.

Otc - Pregnancy Or Breast Feeding

IF PREGNNT OR BREAST-FEEDING, ASK A HEALTHCARE PROFESSIONAL BEFORE USE.

Directions

ADULTS AND CHILDREN OVER 12 YEARS: APPLY TO AFFECTED AREA AND GENTLY MASSAGE OVER AREA UNTIL ABSORBED. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER GEL IS APPLIED.

Inactive Ingredients

Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, Boswelia Serrata Extract, Citrus Limon, Denatured Dehydrated Alcohol 40B, Gaultheria Procumbens (Wintergreen) Leaf Oil Extract, Petasites Japonicus Root (Butterbur) Extract,Pine (Pinetree) Bark Extract, Salix Nigra (Willow) Bark Extract, Zanthoxylum Americanum (Prickly Ash) Bark Extract Zanthoxylum Bungeanum Fruit (Sichuan Peppercorn) Extract, Water

Otc - Questions

QUESTIONS OR COMMENTS? 1-888-551-7778

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