NDC 68788-7434 Lidocaine Hcl 4 Percent And Menthol 4 Percent

Lidocaine Hcl And Menthol

NDC Product Code 68788-7434

NDC CODE: 68788-7434

Proprietary Name: Lidocaine Hcl 4 Percent And Menthol 4 Percent 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 Hcl And Menthol 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

  • 68788 - Preferred Pharmaceuticals, Inc.
    • 68788-7434 - Lidocaine Hcl 4 Percent And Menthol 4 Percent

NDC 68788-7434-1

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Lidocaine Hcl 4 Percent And Menthol 4 Percent with NDC 68788-7434 is a a human over the counter drug product labeled by Preferred Pharmaceuticals, Inc.. The generic name of Lidocaine Hcl 4 Percent And Menthol 4 Percent is lidocaine hcl and menthol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Preferred Pharmaceuticals, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Lidocaine Hcl 4 Percent And Menthol 4 Percent 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 4 g/100mL
  • MENTHOL, UNSPECIFIED FORM 4 g/100mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ALCOHOL (UNII: 3K9958V90M)

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: Preferred Pharmaceuticals, Inc.
Labeler Code: 68788
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: 06-01-2020 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: N - NO 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.

Lidocaine Hcl 4 Percent And Menthol 4 Percent Product Label Images

Lidocaine Hcl 4 Percent And Menthol 4 Percent 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

Other

LIDOCAINE AND MENTHOL - Lidocaine HCl 4% and Menthol 4% topical spray7T Pharma, LLC ----------Lidocaine 4% and Menthol 4% Topical Spray​Drug Facts

Active Ingredient

Lidocaine HCl 4%Menthol 4%

Purpose

Topical anestheticTopical analgesic

Uses

  • Temporarily relieves pain and itching due to: •minor cuts •sunburn •minor scrapes •minor burns •insect bites •minor skin irritations

Warnings

​For external use only.

When Using This Product

  • •do not use in or near the eyes •do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use And Ask A Doctor If

  • •allergic reaction occurs •condition worsens or does not improve within 7 days •symptoms clear up and return within a few days •redness, irritation, swelling, pain or other symptoms begin or increase

Keep Out Of Reach Of Children.

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

Directions

Adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor

Other Information

  • •May be applied under occlusive dressing. •Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Myristoleate, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguaiensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40BLidocaine 4% and Menthol 4% Topical SprayNDC 68788-7434-014 fl oz (118mL)Manufactured for: 7T Pharma, LLCLos Angeles, CA 90064Relabeled by Preferred Pharmaceuticals, Inc.

* Please review the disclaimer below.