NDC 76277-122 Activmend

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

NDC Product Code 76277-122

NDC CODE: 76277-122

Proprietary Name: Activmend What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Arnica Montana, Hypericum Perforatum, Ledum Palustre, Rhus Toxicodendron, Ruta Graveolens, Natrum Muraticum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

NDC 76277-122-32

Package Description: 1 POUCH in 1 BOX > 5 PATCH in 1 POUCH > 14 g in 1 PATCH

NDC Product Information

Activmend with NDC 76277-122 is a a human over the counter drug product labeled by Cearna, Inc.. The generic name of Activmend is arnica montana, hypericum perforatum, ledum palustre, rhus toxicodendron, ruta graveolens, natrum muraticum. The product's dosage form is patch and is administered via topical form.

Labeler Name: Cearna, Inc.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Activmend Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM CHLORIDE 2 [hp_C]/g
  • LEDUM PALUSTRE TWIG 1 [hp_M]/g
  • ARNICA MONTANA 1 [hp_M]/g
  • TOXICODENDRON PUBESCENS LEAF 1 [hp_M]/g
  • RUTA GRAVEOLENS FLOWERING TOP 1 [hp_M]/g
  • HYPERICUM PERFORATUM 1 [hp_M]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TARTARIC ACID (UNII: W4888I119H)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cearna, Inc.
Labeler Code: 76277
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-09-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Activmend Product Label Images

Activmend Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Active Ingredients for Gels: Arnica Montana 1MHypericum Perforatum 1MLedum Palustre 1MRhus toxicodendron 1MRuta graveolens 1MNatrum Muraticum 2C

Otc - Purpose

Purpose: Arnica Montana 1M...........................Bruising, muscle strainHypericum Perforatum 1M ...............PainLedum Palustre 1M.........................Swelling, painRhus toxicodendron 1M...................Sprains, strains, swelling, painRuta graveolens 1M.........................StrainsNatrum Muraticum 2C .......................Sprains

Uses

For the reduction of swelling and pain associated with joint sprains, muscle strains, shin splints, dislocations, overuse injuries, and bruising.

Warnings

  • WarningsFor external use on intact skin onlyUse only as directed.Do not bandage tightly.Stop use and ask a doctor if condition worsens.Do not use in the eyes, over open wounds, or if you have unexpected bleeding.If pregnant or breast-feeding, ask a health professional before use.Do not use if you are allergic to any of this product's active or ingredients.

Do Not Use

Do not use:Do not use in the eyes, over open wounds, or if you have unexpected bleedingDo not use if pouch is opened or damaged.

Stop Use And Ask A Doctor

​Stop use and ask a doctor if condition worsens

Otc - Pregnancy Or Breast Feeding

I
f pregnant or breast-feeding ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Directions:Adults and Children 12 years of age and overClean and dry affected area.Remove patch from film.Place healing pads on intact skin.Wear one activMend patch up to 24 hours.Children under 12 years of age - Consult a doctor

Other Information

  • Store at room temperature.Do not freeze.Tightly reseal pouch containing unused patches.

Inactive Ingredients

Glycerin

Dihydroxyaluminum aminoacetate (Al-glycinate)

Titanium dioxide (TiO2)

1,2-hexanediol

Sodium Carbomethylcellulose (CMC-Na)

Partially neutralized polyacrylate

Disodium Edetatate (EDTA-2Na)

Tartaric acid

Water

Ethanol

Questions?

Questions: 1-855-255-MEND (6363)
or email: Support@ActivMend.com

Other

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.Do not use if pouches are open.

* Please review the disclaimer below.