Meijer Pain Relieving Analgesic
Camphor (synthetic) And Menthol, Unspecified Form
Meijer Distribution, Inc
Human Otc Drug
NDC 79481-0051Meijer Pain Relieving Analgesic also known as Camphor (synthetic) And Menthol, Unspecified Form is a human otc drug labeled by 'Meijer Distribution, Inc'. National Drug Code (NDC) number for Meijer Pain Relieving Analgesic is 79481-0051. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Meijer Pain Relieving Analgesic drug includes Camphor (synthetic) - 55 mg/g Menthol, Unspecified Form - 160 mg/g . The currest status of Meijer Pain Relieving Analgesic drug is Active.
Drug Information:
| Drug NDC: | 79481-0051 |
| 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: | Meijer Pain Relieving Analgesic |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Meijer Pain Relieving |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | analgesic |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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 (synthetic) And Menthol, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Meijer Distribution, Inc |
| 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) - 55 mg/g
MENTHOL, UNSPECIFIED FORM - 160 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: | 05 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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, 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: | Meijer Distribution, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2624710
|
| 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. |
| 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 |
|---|
| 79481-0051-1 | 77 g in 1 TUBE (79481-0051-1) | 05 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:
Active ingredient purpose camphor 5.5% topical analgesic menthol 16% topical analgesic
Product Elements:
Meijer pain relieving analgesic camphor (synthetic) and menthol, unspecified form camphor (synthetic) camphor (synthetic) menthol, unspecified form menthol, unspecified form alcohol aminomethylpropanol indian frankincense carbomer homopolymer, unspecified type edetate disodium ethylhexylglycerin eucalyptus polybractea leaf oil clove oil glycerin linseed oil peppermint oil 3-((l-menthyl)oxy)propane-1,2-diol pentylene glycol phenoxyethanol polysorbate 80 rosemary oil spanish thyme oil vanillyl butyl ether water
Indications and Usage:
Use for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Warnings:
Warnings for external use only flammable: keep away from fire or flame do not use: if you ever had an allergic reaction to this product or any of its ingredients. when using this product ? avoid contact with eyes ? do not apply to wounds or damaged skin ? do not bandage tightly ? do not use in large quantities ? do not use with heating pads, medicated patches or heating devices. stop use and ask a doctor if ? condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ? pain, swelling, blistering develops where product is used ? redness or severe burning sensation develops where product is used. if you are pregnant or nursing, seek the advice of a health professional before using. keep out of reach of children . if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
Do Not Use:
Warnings for external use only flammable: keep away from fire or flame do not use: if you ever had an allergic reaction to this product or any of its ingredients. when using this product ? avoid contact with eyes ? do not apply to wounds or damaged skin ? do not bandage tightly ? do not use in large quantities ? do not use with heating pads, medicated patches or heating devices. stop use and ask a doctor if ? condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ? pain, swelling, blistering develops where product is used ? redness or severe burning sensation develops where product is used. if you are pregnant or nursing, seek the advice of a health professional before using. keep out of reach of children . if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product ? avoid contact with eyes ? do not apply to wounds or damaged skin ? do not bandage tightly ? do not use in large quantities ? do not use with heating pads, medicated patches or heating devices.
Dosage and Administration:
Directions adults and children 12 years of age and older: ? apply to affected area not more than 3 to 4 times daily. children under 12 years of age: consult a doctor.
Stop Use:
Stop use and ask a doctor if ? condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ? pain, swelling, blistering develops where product is used ? redness or severe burning sensation develops where product is used.
Package Label Principal Display Panel:
Principal display panel - 77 g tube label meijer ® compare to alevex ® pain relieving lotion active ingredients* pain relieving lotion camphor 5.5% menthol 16% topical analgesic with maximum strength menthol net wt 2.7 oz (77g) principal display panel - 77 g tube label
Further Questions:
Questions or comments? 1-866-567-8600