Cvs Health Lidocaine Pain-relieving
Lidocaine
Natural Essentials, Inc.
Human Otc Drug
NDC 66902-450Cvs Health Lidocaine Pain-relieving also known as Lidocaine is a human otc drug labeled by 'Natural Essentials, Inc.'. National Drug Code (NDC) number for Cvs Health Lidocaine Pain-relieving is 66902-450. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Cvs Health Lidocaine Pain-relieving drug includes . The currest status of Cvs Health Lidocaine Pain-relieving drug is Active.
Drug Information:
| Drug NDC: | 66902-450 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cvs Health Lidocaine Pain-relieving |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Lidocaine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Natural Essentials, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TRANSDERMAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 02 Jun, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | NATURAL ESSENTIALS, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1737778
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0050428629062
|
| UPC stands for Universal Product Code. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 66902-450-06 | 1 KIT in 1 CARTON (66902-450-06) * 2 PATCH in 1 NOT APPLICABLE (66902-270-02) / 11 g in 1 PATCH * 2 PATCH in 1 NOT APPLICABLE (66902-270-03) / 23 g in 1 PATCH * 2 PATCH in 1 NOT APPLICABLE (66902-270-01) / 7 g in 1 PATCH | 02 Jun, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Product Elements:
Cvs health lidocaine pain-relieving lidocaine cvs health lidocaine pain-relieving lidocaine lidocaine lidocaine dihydroxyaluminum aminoacetate anhydrous glycerin kaolin methylparaben polyacrylic acid (8000 mw) polysorbate 80 propylene glycol propylparaben povidone, unspecified sodium polyacrylate (8000 mw) tartaric acid titanium dioxide water cvs health lidocaine pain-relieving lidocaine lidocaine lidocaine dihydroxyaluminum aminoacetate anhydrous glycerin kaolin methylparaben polyacrylic acid (8000 mw) polysorbate 80 propylene glycol propylparaben povidone, unspecified sodium polyacrylate (8000 mw) tartaric acid titanium dioxide water cvs health lidocaine pain-relieving lidocaine lidocaine lidocaine dihydroxyaluminum aminoacetate anhydrous glycerin kaolin methylparaben polyacrylic acid (8000 mw) polysorbate 80 propylene glycol propylparaben povidone, unspecified sodium polyacrylate (8000 mw) tartaric acid titanium dioxide water
Indications and Usage:
Use for the temporary relief of pain.
Warnings:
Warnings for external use only do not use more than 1 patch on your body at a time 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 use more than one patch in an 8 hour period. maximum 3 patches per day. rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not allow contact with the eyes and mucous membranes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets. used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch note: patches may not adhere as well to all individuals, skin types, or cer
Read more...tain parts of the body. stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied if pregnant or breast feeding ask a physician before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only do not use more than 1 patch on your body at a time 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 use more than one patch in an 8 hour period. maximum 3 patches per day. rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not allow contact with the eyes and mucous membranes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets. used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch note: patches may not adhere as well to all individuals, skin types, or certain parts of the body. stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied if pregnant or breast feeding ask a physician before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product use only as directed. read and follow all directions and warnings on this carton. do not use more than one patch in an 8 hour period. maximum 3 patches per day. rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken or irritated skin do not allow contact with the eyes and mucous membranes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in manner that always keeps product away from children and pets. used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch note: patches may not adhere as well to all individuals, skin types, or certain parts of the body.
Dosage and Administration:
Directions adults/children 12 years and older clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area once applied, press firmly and rub on all sides and center of patch to help adhesive adhere to skin do not remove patch and reapply, this will result in the patch not sticking a avoid strenuous exercise while wearing patch, this will result in patch not sticking do not use more than one patch in an 8 hour period. children 12 years or younger: ask a doctor.
Stop Use:
Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Package Label Principal Display Panel:
Principal display panel â small patch label cut open pouch and remove patch cvs health ® compare to the active ingredient in salonpas ® 4% lidocaine gel patch* maximum strength lidocaine concentration without a prescription â lidocaine pain-relieving patch lidocaine 4% gel desensitizes aggravated nerves fast acting easy to apply no irritation or burning unscented â among over the counter topical analgesics. 1 patch | small 3 1/8â x 4 3/4â (8 cm x 12 cm) principal display panel â small patch label
Principal display panel â medium patch label cut open pouch and remove patch cvs health® compare to the active ingredient in salonpas ® 4% lidocaine gel patch* maximum strength lidocaine concentration without a prescription â lidocaine pain-relieving patch lidocaine 4% gel desensitizes aggravated nerves fast acting easy to apply no irritation or burning unscented â among over the counter topical analgesics. 1 patch | medium 3 15/16â x 5 1/2â (10 cm x 14 cm) principal display panel â medium patch label
Principal display panel â x large patch label cut open pouch and remove patch cvs health ® compare to the active ingredient in salonpas ® 4% lidocaine gel patch* maximum strength lidocaine concentration without a prescription â lidocaine pain-relieving patch lidocaine 4% gel desensitizes aggravated nerves fast acting easy to apply no irritation or burning unscented â among over the counter topical analgesics. 1 patch | x large 5 1/2â x 9 7/8â (14 cm x 25 cm) principal display panel â x large patch label
Principal display panel â carton label cvs health ® compare to the active ingredients in salonpas ® 4% lidocaine gel patch* maximum strength lidocaine concentration without a prescription â lidocaine pain-relieving patches lidocaine 4% gel desensitizes aggravated nerves fast acting easy to apply no irritation or burning unscented 6 assorted size patches 2 sm 3 1/8â x 4 ¾â (8 cm x 12 cm) 2 med 3 15/16â x 5 1/2â (10 cm x 14 cm) 2 xl 5 1/2â x 9 7/8â (14 cm x 25 cm) assorted sizes principal display panel â carton label