NDC 50421-004 Camphor, Menthol

NDC Product Code 50421-004

NDC 50421-004-34

Package Description: 115 g in 1 TUBE

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

NDC Product Information

Camphor, Menthol with NDC 50421-004 is a product labeled by Active & Innovative Inc.. The generic name of Camphor, Menthol is . The product's dosage form is and is administered via form.

Labeler Name: Active & Innovative Inc.

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.

  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SORBIC ACID (UNII: X045WJ989B)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • THYMOL (UNII: 3J50XA376E)
  • UREA (UNII: 8W8T17847W)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • WATER (UNII: 059QF0KO0R)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)

Product Labeler Information

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

Labeler Name: Active & Innovative Inc.
Labeler Code: 50421
Start Marketing Date: 01-13-2010 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: 12-31-2017 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".

* Please review the disclaimer below.

Camphor, Menthol 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 (% By Weight)

Camphor4.0%Menthol 4.0%

Purpose

Analgesic (pain relief)

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Warnings

  • For external use only.Avoid getting into eyes or on mucous membranes.If the conditions worsens, or if the symptoms persists for more than 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a doctor.Do not apply to wounds or damaged skin. Do not bandage tightly.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

Other Warnings

  • Use only as directed.Do not use if pregnant or breastfeeding.If swallowed, get medical help or contact a poison Control center right away.

Directions

Adults and children 12 years of age or older: Rub this soothing cream on the affected area not more that 3 to 4 times daily.Children under the age of 12: Do not use, consult a doctor.

Other Information

Store under normal storage conditions. Store away from Children.

Inactive Ingredients

Caprylyl glycol, cetyl alcohol, chondroitin sulphate, eucalyptus oil, glucosamine sulfate, glycerin, glycol stearate, grape seed oil, C13-14 isoparaffin, Laureth-7, lavender oil, methylsulfonyl-methane (MSM), phenoxyethanol, polyacrylamide, polysorbate-20, sea cucumber extract, sorbic acid, stearyl alcohol, thymol, urea, Vitamin E (tocopheral acetate), water, wintergreen oil.

Questions?

Questions? 416-967-3746

* Please review the disclaimer below.