Tricalm Hydrogel
Aluminum Acetate
Modular Thermal Technologies Llc Dba Life Wear Technologies
Human Otc Drug
NDC 71207-100Tricalm Hydrogel also known as Aluminum Acetate is a human otc drug labeled by 'Modular Thermal Technologies Llc Dba Life Wear Technologies'. National Drug Code (NDC) number for Tricalm Hydrogel is 71207-100. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Tricalm Hydrogel drug includes Aluminum Acetate - 2 mg/mL . The currest status of Tricalm Hydrogel drug is Active.
Drug Information:
| Drug NDC: | 71207-100 |
| 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: | Tricalm Hydrogel |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Tricalm |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Hydrogel |
| 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: | Aluminum Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Modular Thermal Technologies Llc Dba Life Wear Technologies |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | ALUMINUM ACETATE - 2 mg/mL
|
| 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 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: | 01 Nov, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | part347 |
| 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: | Modular Thermal Technologies LLC Dba Life Wear Technologies
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1594642
1594647
|
| 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: | 80EHD8I43D
|
| 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 |
|---|
| 71207-100-10 | 1 TUBE in 1 CARTON (71207-100-10) / 60 mL in 1 TUBE | 02 Nov, 2016 | N/A | No |
| 71207-100-20 | 1 TUBE in 1 CARTON (71207-100-20) / 60 mL in 1 TUBE | 02 Nov, 2016 | 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 astringent
Product Elements:
Tricalm hydrogel aluminum acetate aluminum acetate aluminum cation butylene glycol caprylyl glycol dehydroacetic acid ethylhexylglycerin glycine hexylene glycol malic acid phenoxyethanol water strontium chloride hexahydrate xanthan gum
Indications and Usage:
Uses for temporary relief of minor skin irritations due to: poison ivy poison oak poison sumac insect bites athlete's foot rashes caused by soaps, detergents, cosmetics or jewelry
Warnings:
Warnings for external use only. when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. do not apply to open wounds. stop use and ask a doctor if condition worsens or symptoms last for more than 7 days. 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 avoid contact with eyes. if contact occurs, rinse thoroughly with water. do not apply to open wounds.
Dosage and Administration:
Directions adults and children two years of age and older, apply to affected area as needed or as directed by a physician. consult a physician for children under the age of two.
Stop Use:
Stop use and ask a doctor if condition worsens or symptoms last for more than 7 days.
Package Label Principal Display Panel:
Principal display panel - 60 ml vertical carton tricalm ® rapid relief from itching, burning & stinging soothing itch relief hydrogel steroid-free aluminum acetate astringent 2 fl oz (60ml) principal display panel - 60 ml vertical carton
Principal display panel tube tricalm steroid-free hydrogel for itching burning and stinging 2.0 floz ( 60ml) principal display panel tube
Further Questions:
Questions? call 855-tri-calm