NDC 50804-775 Maximum Stremgth Pain Relief Good Sense

Lidocaine Hcl 4%

NDC Product Code 50804-775

NDC Code: 50804-775

Proprietary Name: Maximum Stremgth Pain Relief Good Sense Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine Hcl 4% Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 50804 - Good Sense
    • 50804-775 - Maximum Stremgth Pain Relief

NDC 50804-775-03

Package Description: 77 g in 1 CONTAINER

NDC Product Information

Maximum Stremgth Pain Relief Good Sense with NDC 50804-775 is a a human over the counter drug product labeled by Good Sense. The generic name of Maximum Stremgth Pain Relief Good Sense is lidocaine hcl 4%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Good Sense

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.


Maximum Stremgth Pain Relief Good Sense 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 4 g/100g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETETH-20 PHOSPHATE (UNII: 921FTA1500)
  • DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ALCOHOL (UNII: 3K9958V90M)
  • STEARETH-21 (UNII: 53J3F32P58)
  • WATER (UNII: 059QF0KO0R)

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: Good Sense
Labeler Code: 50804
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: 01-15-2019 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: 12-31-2019 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.

Maximum Stremgth Pain Relief Good Sense Product Label Images

Maximum Stremgth Pain Relief Good Sense 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                                               Purpose

Lidocaine HCl 4%                                              Topical Analgesic

Uses

Uses For temporary relief of pain and itching

Warnings

​For external use onlyWhen using this product​ ​• use only as directed • do not bandage tightly • avoid contact with eyes • do not apply to wounds or damaged skin • do not use in large quantities, particularly over raw surfaces or blistered areas.Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of The Children.

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

​Adults and children 2 years of age and older:​ Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone,  Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, SD Alcohol 40, Steareth-21, Water

* Please review the disclaimer below.

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