NDC 55628-9107 Ultracin M

NDC Product Code 55628-9107

NDC 55628-9107-4

Package Description: 120 mL in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Ultracin M with NDC 55628-9107 is a product labeled by Cal Pharma. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 415975.

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)

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
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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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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

* Please review the disclaimer below.