Cvs Pain Relieving
Camphor 5.5% Menthol 16%
Cvs
Human Otc Drug
NDC 51316-885Cvs Pain Relieving also known as Camphor 5.5% Menthol 16% is a human otc drug labeled by 'Cvs'. National Drug Code (NDC) number for Cvs Pain Relieving is 51316-885. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Cvs Pain Relieving drug includes Camphor (synthetic) - 16 mg/g Menthol - 5.5 mg/g . The currest status of Cvs Pain Relieving drug is Active.
Drug Information:
| Drug NDC: | 51316-885 |
| 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 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: | Camphor 5.5% Menthol 16% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | CAMPHOR (SYNTHETIC) - 16 mg/g
MENTHOL - 5.5 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 19 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Jun, 2026 |
| 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, 2023 |
| 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: | CVS
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 5TJD82A1ET
L7T10EIP3A
|
| 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 |
|---|
| 51316-885-16 | 72 g in 1 TUBE (51316-885-16) | 19 Dec, 2022 | 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:
Pain relieving lotion
Product Elements:
Cvs pain relieving camphor 5.5% menthol 16% camphor (synthetic) camphor (synthetic) menthol menthol water carbomer interpolymer type a (55000 cps) glycerin polysorbate 80 edetate disodium anhydrous .alpha.-tocopherol acetate sorbitan monooleate pentylene glycol phenoxyethanol peppermint oil clove oil alcohol eucalyptus oil
Indications and Usage:
For the temporary relief of minor aches and pains of muscles and joints associated with arthritis simple backache strains sprains bruises provides penetrating pain relief
Warnings:
For extranal use only avoid contact with eyes and mucous membranes do not bandage tightly do not use with a heating pad, medicated patch or other of local heat do not apply to wounds or damaged, broken or irritated skin condition worsens or irritation develops pain, swelling or blistering develops where product was applied redness or severe burning develops when product was applied 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. if swallowed, get medical help or contact a poison control center right away.
When Using:
Avoid contact with eyes and mucous membranes do not bandage tightly do not use with a heating pad, medicated patch or other of local heat do not apply to wounds or damaged, broken or irritated skin
Dosage and Administration:
Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily wash hands with soap and water after use if product comes with hands children under 12 years of age ask a doctor
Stop Use:
Condition worsens or irritation develops pain, swelling or blistering develops where product was applied redness or severe burning develops when product was applied symptoms persist for more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Package carton