NDC 73313-075 Sugar Brands Rescue Pain Relief And Recovery

Lidocaine Hydrochloride

NDC Product Code 73313-075

NDC Code: 73313-075

Proprietary Name: Sugar Brands Rescue Pain Relief And Recovery What 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 Hydrochloride What 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.

NDC Code Structure

  • 73313 - Sugar Brands, Llc
    • 73313-075 - Sugar Brands Rescue Pain Relief And Recovery

NDC 73313-075-04

Package Description: 118 mL in 1 TUBE

NDC Product Information

Sugar Brands Rescue Pain Relief And Recovery with NDC 73313-075 is a a human over the counter drug product labeled by Sugar Brands, Llc. The generic name of Sugar Brands Rescue Pain Relief And Recovery is lidocaine hydrochloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sugar Brands, Llc

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 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.

Sugar Brands Rescue Pain Relief And Recovery 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.

  • LIDOCAINE HYDROCHLORIDE 40 mg/mL

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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • HORSE CHESTNUT (UNII: 3C18L6RJAZ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • .BETA.-ALANINE (UNII: 11P2JDE17B)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • ARGININE (UNII: 94ZLA3W45F)
  • LEVOCARNITINE (UNII: 0G389FZZ9M)
  • CITRULLINE (UNII: 29VT07BGDA)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BLACK CURRANT (UNII: 9755T40D11)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Sugar Brands, Llc
Labeler Code: 73313
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: 08-20-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Sugar Brands Rescue Pain Relief And Recovery Product Label Images

Sugar Brands Rescue Pain Relief And Recovery 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 4.00%

Purpose

Topical Analgesic

Uses

  • For the temporary relief of 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 Use

In large quantities, particularly over raw surfaces or blistered areas.

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/C10-30 Alkyl Acrylate Crosspolymer, Aesculus Hippocastanum (Horse Chestnut) Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Beta Alanine, Betaglucan, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, Cetyl Esters, Dimethicone, Ethoxydiglycol, Ethylhexylglycerin, Ethyl Vanillin, Eucalyptus Globulus Oil, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, l-Arginine, l-Carnitine, l-Citruline, Magnesium Sulfate, Methyl Gluceth-20, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Ribes Nigrum (Black Currant) Oil, Salix Alba (Willow) Bark Extract, Steareth-20, Triethanolamine.

* Please review the disclaimer below.