NDC 72859-890 Cool Cure Pain Relief

Lidocaine Hydrochloride

NDC Product Code 72859-890

NDC Product Information

Cool Cure Pain Relief with NDC 72859-890 is a a human over the counter drug product labeled by Sdrh Inc. The generic name of Cool Cure Pain Relief is lidocaine hydrochloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sdrh Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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 Additional informationCallout TooltipWhat 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.


Cool Cure Pain Relief Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LIDOCAINE HYDROCHLORIDE 40 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • EMU OIL (UNII: 344821WD61)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LICORICE (UNII: 61ZBX54883)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • TROLAMINE (UNII: 9O3K93S3TK)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sdrh Inc
Labeler Code: 72859
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-22-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Cool Cure Pain Relief Product Label Images

Cool Cure Pain Relief 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:

Lidocaine HCl

Indications:

Temporary relief of minor pain.

Warnings

  • For external use only. Avoid contact with eyes.If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

If swallowed, consult physician.

Do Not Apply

  • To wounds or damaged skin.Do not bandage tightly.

If Pregnant Or Breast Feeding,

Contact physician prior to use.

Directions:

  • Adults and children two-years of age or older: apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Camphor, Cetyl Esters, Cetyl Myristoleate, Dimethicone, DMDM Hydantoin, Emu Oil, Ethylhexylglycerin, Ethoxydiglycol, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Gluceth 20, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Salix Alba (Willow) Bark Extract, Steareth-20, Tocopheryl Acetate (Vitamin E) Triethanolamine.

* Please review the disclaimer below.

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