NDC 69842-029 Lidocaine Pain Relief Roll-on

Lidocaine 4%

NDC Product Code 69842-029

NDC Code: 69842-029

Proprietary Name: Lidocaine Pain Relief Roll-on 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 4% 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

  • 69842 - Cvs Pharmacy
    • 69842-029 - Lidocaine Pain Relief Roll-on

NDC 69842-029-97

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 74 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Lidocaine Pain Relief Roll-on with NDC 69842-029 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Lidocaine Pain Relief Roll-on is lidocaine 4%. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cvs Pharmacy

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Pain Relief Roll-on 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

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.

  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • WATER (UNII: 059QF0KO0R)
  • STEARETH-21 (UNII: 53J3F32P58)
  • ALCOHOL (UNII: 3K9958V90M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
  • CETETH-20 PHOSPHATE (UNII: 921FTA1500)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)

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: Cvs Pharmacy
Labeler Code: 69842
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: 06-05-2019 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.

Lidocaine Pain Relief Roll-on Product Label Images

Lidocaine Pain Relief Roll-on 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

Dosage & Administration

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor.

Inactive Ingredient

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-2, steareth-21, water

Otc - Active Ingredient

Lidocaine 4%

Warnings

For External Use Only.When using this product:use only as directeddo not bandage tightly or use with a heating padavoid contact with eyesdo not apply to wounds or damaged skindo not use in large quantitiespartifcularly over raw surfaces or blistered areas

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

For temporarily relief of pain and itching.

Otc - Purpose

Topical analgesic

* Please review the disclaimer below.

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