Meijer Extra Strength Cold And Hot Therapypain Relieving Topical Analgesic
Menthol, Unspecified Form And Methyl Salicylate
Meijer Distribution, Inc
Human Otc Drug
NDC 41250-378Meijer Extra Strength Cold And Hot Therapypain Relieving Topical Analgesic also known as Menthol, Unspecified Form And Methyl Salicylate is a human otc drug labeled by 'Meijer Distribution, Inc'. National Drug Code (NDC) number for Meijer Extra Strength Cold And Hot Therapypain Relieving Topical Analgesic is 41250-378. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Meijer Extra Strength Cold And Hot Therapypain Relieving Topical Analgesic drug includes Menthol, Unspecified Form - 100 mg/g Methyl Salicylate - 300 mg/g . The currest status of Meijer Extra Strength Cold And Hot Therapypain Relieving Topical Analgesic drug is Active.
Drug Information:
| Drug NDC: | 41250-378 |
| 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 Extra Strength Cold And Hot Therapypain Relieving Topical Analgesic |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Meijer Extra Strength Cold And Hot Therapypain Relieving |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Topical 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: | Menthol, Unspecified Form And Methyl Salicylate |
| 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: | Cream |
| 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: | MENTHOL, UNSPECIFIED FORM - 100 mg/g
METHYL SALICYLATE - 300 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: | 30 Nov, 2020 |
| 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: | 311500
|
| 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: | L7T10EIP3A
LAV5U5022Y
|
| 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 |
|---|
| 41250-378-01 | 1 TUBE in 1 CARTON (41250-378-01) / 35.4 g in 1 TUBE | 30 Nov, 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:
Active ingredients purpose menthol 10% topical analgesic methyl salicylate 30% topical analgesic
Product Elements:
Meijer extra strength cold and hot therapypain relieving topical analgesic menthol, unspecified form and methyl salicylate menthol, unspecified form menthol, unspecified form methyl salicylate salicylic acid carbomer interpolymer type a (allyl sucrose crosslinked) carbomer homopolymer, unspecified type polyoxyl 20 cetostearyl ether cetostearyl alcohol oleth-3 phosphate phenoxyethanol polysorbate 60 sodium hydroxide stearic acid water
Indications and Usage:
Uses temporarily relieves minor pain associated with: muscle sprains muscle strains simple backache bruises arthritis
Warnings:
Warnings for external use only test on a small patch before applying generously. allergy alert if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. when using this product use only as directed. read and follow all directions and warnings on this label do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch avoid contact with eyes or mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears in seven days 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 irritation develops you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a
Read more... poison control center (1-800-222-1222) right away.
When Using:
When using this product use only as directed. read and follow all directions and warnings on this label do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch avoid contact with eyes or mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears in seven days
Dosage and Administration:
Directions adults and children over 12 years: apply to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 4 times daily after applying, wash hands with soap and water . children 12 years or younger: ask a doctor
Stop 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 irritation develops 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 - 35.4 g tube carton compare to icy hot ® active ingredients* meijer ® extra strength cold & hot therapy menthol 10% (topical anangesic) methyl salicylate 30% (topical anangesic) pain relieving cream body & backache | bruises | arthritis | sore muscles net wt 1.25 oz (35.4 g) principal display panel - 35.4 g tube carton
Further Questions:
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