Absorbine Jr. Plus
Menthol
Clarion Brands, Llc
Human Otc Drug
NDC 69693-411Absorbine Jr. Plus also known as Menthol is a human otc drug labeled by 'Clarion Brands, Llc'. National Drug Code (NDC) number for Absorbine Jr. Plus is 69693-411. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Absorbine Jr. Plus drug includes Menthol - 4 g/100mL . The currest status of Absorbine Jr. Plus drug is Active.
Drug Information:
| Drug NDC: | 69693-411 |
| 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: | Absorbine Jr. Plus |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Absorbine Jr. |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Plus |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Clarion Brands, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 4 g/100mL
|
| 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: | 24 Jun, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 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: | Clarion Brands, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 283438
751892
|
| 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
|
| 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 |
|---|
| 69693-411-04 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (69693-411-04) / 118 mL in 1 BOTTLE, WITH APPLICATOR | 24 Jun, 2010 | 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:
Absorbine jr. plus menthol acetone fd&c blue no. 1 iodine calendula officinalis flower echinacea, unspecified wormwood potassium iodide thymol water wormwood oil menthol menthol
Indications and Usage:
Uses for temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache sprains strains bruises
Warnings:
Warnings for external use only. use only as directed. flammable keep away from fire, flame, sparks and heated surfaces. tighten cap firmly.
When Using:
When using this product avoid contact with the eyes do not apply to wounds or damaged skin do not bandage tightly
Dosage and Administration:
Directions 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
Stop Use:
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
Package Label Principal Display Panel:
Principal display panel extra strength formula absorbine jr. ® plus pain relieving liquid fast absorbing for rapid relief relieves: ⢠sore muscles ⢠arthritis pain no mess applicator keeps hands clean 4 fl oz (118 ml) our fast absorbing, deep penetrating extra strength formula provides even more relief to sore muscles, arthritis pain & stiffness fast relief from; ⢠sore muscles & cramps ⢠aching joints & stiffness ⢠arthritis pain ⢠bruises ⢠sprains ⢠strains ⢠backache ⢠foot pain & discomfort our extra strength formula is: ⢠fast acting ⢠easy to apply ⢠quick-drying ⢠non-greasy ⢠non-stinging made with pride in the u.s.a. distributed by: clarion brands, llc 27070 miles rd., suite a solon, oh 44139 1-844-922-7672 88749a www.absorbinejr.com extra strength formula absorbine jr. ® plus pain relieving liquid fast absorbing for rapid relief relieves: ⢠sore muscles ⢠arthritis pain no mess applicator keeps hands clean 4 fl oz (118 ml) our fast absorbing, deep penetrating extra strength formula provides even more relief to sore muscles, arthritis pain & stiffness fast relief from; ⢠sore muscles & cramps ⢠aching joints & stiffness ⢠arthritis pain ⢠bruises ⢠sprains ⢠strains ⢠backache ⢠foot pain & discomfort distributed by: clarion brands, llc 27070 miles rd., suite a, solon, oh 44139 1-844-922-7672 l499294110a www.absorbinejr.com ajrevb.jpg absorbine jr. plus carton absorbine jr. plus label
Further Questions:
Questions? call 1-844-922-7672