Activmend

Arnica Montana, Hypericum Perforatum, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens, Natrum Muraticum


Cearna, Inc.
Human Otc Drug
NDC 76277-122
Activmend also known as Arnica Montana, Hypericum Perforatum, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens, Natrum Muraticum is a human otc drug labeled by 'Cearna, Inc.'. National Drug Code (NDC) number for Activmend is 76277-122. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Activmend drug includes Arnica Montana - 1 [hp_M]/g Hypericum Perforatum - 1 [hp_M]/g Ledum Palustre Twig - 1 [hp_M]/g Ruta Graveolens Flowering Top - 1 [hp_M]/g Sodium Chloride - 2 [hp_C]/g Toxicodendron Pubescens Leaf - 1 [hp_M]/g . The currest status of Activmend drug is Active.

Drug Information:

Drug NDC: 76277-122
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: Activmend
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: Arnica Montana, Hypericum Perforatum, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens, Natrum Muraticum
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Cearna, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Patch
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:ARNICA MONTANA - 1 [hp_M]/g
HYPERICUM PERFORATUM - 1 [hp_M]/g
LEDUM PALUSTRE TWIG - 1 [hp_M]/g
RUTA GRAVEOLENS FLOWERING TOP - 1 [hp_M]/g
SODIUM CHLORIDE - 2 [hp_C]/g
TOXICODENDRON PUBESCENS LEAF - 1 [hp_M]/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: UNAPPROVED HOMEOPATHIC
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: 09 Feb, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 11 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.
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:Cearna, Inc.
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:O80TY208ZW
XK4IUX8MNB
877L01IZ0P
N94C2U587S
451W47IQ8X
6IO182RP7A
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.
Pharmacologic Class:Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
76277-122-321 POUCH in 1 BOX (76277-122-32) / 5 PATCH in 1 POUCH / 14 g in 1 PATCH08 Jul, 2021N/ANo
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 arnica montana 1m hpus, 10.8%................bruising, muscle strain hypericum perforatum 1m hpus, 10.8%.................pain ledum palustre 1m hpus, 10.8%..............swelling, pain rhus toxicodendron 1m hpus, 10.8%................sprains, strains, swelling, pain ruta graveolens 1m hpus, 10.8%..............strains natrum muraticum 2c hpus, 10.8%......................sprains the letter hpus indicate that this ingredient is officially included in the homeopathic pharmacopoeia of the united states.

Product Elements:

Activmend arnica montana, hypericum perforatum, ledum palustre, rhus toxicodendron, ruta graveolens, natrum muraticum hypericum perforatum hypericum perforatum alcohol dihydroxyaluminum aminoacetate 1,2-hexanediol edetate disodium water acrylic acid/sodium acrylate copolymer (1:1; 600 mpa.s at 0.2%) tartaric acid sodium polyacrylate (8000 mw) carboxymethylcellulose sodium glycerin titanium dioxide toxicodendron pubescens leaf toxicodendron pubescens leaf sodium chloride sodium cation ledum palustre twig ledum palustre twig arnica montana arnica montana ruta graveolens flowering top ruta graveolens flowering top

Indications and Usage:

Uses for the reduction of swelling and pain associated with joint sprains, muscle strains, shin splints, dislocations, overuse injuries and bruising. claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Warnings:

Warnings for external use on intact skin only do not use if you are allergic to any of this product's active or inactive ingredients. when using this product use only as directed do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin ​stop use and ask a doctor if condition worsens irritation occurs symptoms persist for more than 7 days or clear up and occur again within a few days i f pre gnant or breastfeeding, 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.

Do Not Use:

Warnings for external use on intact skin only do not use if you are allergic to any of this product's active or inactive ingredients. when using this product use only as directed do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin ​stop use and ask a doctor if condition worsens irritation occurs symptoms persist for more than 7 days or clear up and occur again within a few days i f pre gnant or breastfeeding, 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:

When using this product use only as directed do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin

Dosage and Administration:

Directions adults and children 12 years of age and over clean and dry affected area remove patch from film place healing patch on intact skin wear one activmend patch up to 24 hours. children under 12 years of age consult a doctor

Stop Use:

​stop use and ask a doctor if condition worsens irritation occurs 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 ndc #76277-122-32 activmend healing gel patches for the reduction of pain, swelling and bruising. 5 homeopathic recovery patches per box 4" x 5.5" each (10 cm x 14 cm) 1

Further Questions:

Questions? 1-855-255-mend or email: support@activmend.com


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.