NDC 76168-315 Rite Aid Pain Relief Cream Lidocaine 4%

Lidocaine Hydrochloride

NDC Product Code 76168-315

NDC 76168-315-27

Package Description: 1 TUBE in 1 CARTON > 76.5 g in 1 TUBE

NDC Product Information

Rite Aid Pain Relief Cream Lidocaine 4% with NDC 76168-315 is a a human over the counter drug product labeled by Velocity Pharma Llc. The generic name of Rite Aid Pain Relief Cream Lidocaine 4% is lidocaine hydrochloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Velocity Pharma 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.

Rite Aid Pain Relief Cream Lidocaine 4% 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/100g

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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETETH-2 (UNII: 7H8VAM7778)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBIC ACID (UNII: X045WJ989B)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Velocity Pharma Llc
Labeler Code: 76168
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: 06-17-2019 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.

Rite Aid Pain Relief Cream Lidocaine 4% Product Label Images

Rite Aid Pain Relief Cream Lidocaine 4% 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

Lidocaine Pain Relieving Creme

Drug Facts

Active Ingredient

Lidocaine HCI 4%

Purpose

Topical anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

  • On large areas of the body or on cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor

When Using This Product

  • Use only as directed. Read and follow all directions and warnings on this carton.
  • Do not allow contact with the eyes
  • Do not bandage or apply local heat (such as heating pads) to the area of use

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children And Pets.

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

Directions

  • Adults and children over 12 years:
  • Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour periodchildren 12 years and younger: ask a doctor

Inactive Ingredients

Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jellyKeep Carton As It Contains Important InformationClose cap tightly between uses.

* Please review the disclaimer below.