NDC 53499-6492 Sports For Trauma

Bellis Perennis, Hypericum Perfomatum, Toxicodendron Pubscens Leaf, Ruta Graveolens Flowering Top

NDC Product Code 53499-6492

NDC CODE: 53499-6492

Proprietary Name: Sports For Trauma 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: Bellis Perennis, Hypericum Perfomatum, Toxicodendron Pubscens Leaf, Ruta Graveolens Flowering Top 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.

NDC Code Structure

  • 53499 - Schwabe North America, Inc

NDC 53499-6492-8

Package Description: 1 TUBE in 1 CARTON > 70 g in 1 TUBE

NDC Product Information

Sports For Trauma with NDC 53499-6492 is a a human over the counter drug product labeled by Schwabe North America, Inc. The generic name of Sports For Trauma is bellis perennis, hypericum perfomatum, toxicodendron pubscens leaf, ruta graveolens flowering top. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Sports For Trauma 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.


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)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Schwabe North America, Inc
Labeler Code: 53499
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: 09-03-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sports For Trauma 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

Contains 5% Bellis perennis 1XCotnains 5% Hypericum perforatum 2XContains 5% Rhus Tox 4XContains 5% Ruta graveolens 1X

Inactive Ingredients

CarbomerEthyl AlcoholEucalyptus OilPurified WaterSodium Hydroxide

Dosage & Administration

Adults and children 6 years of age and older:Apply to affected area up to 4 times daily. Rub in gently.Children under 6 years of age: Consult a doctor.Patch test recommended on sensitive skin.

Indications And Usage

Temporarily relieves deep muscle and back pain, stiffness, and swelling associated with overexertion, sprains, falls, blows and minor sports injuries.Relieves joint and tendon pain and inflammation.

Purpose

Temporarily relieves deep muscle and back pain, stiffness, and swelling associated with overexertion, sprains, falls, blows and minor sports injuries.Relieves joint and tendon pain and inflammation.

Warning

For external use only. Avoid contact with eyes or broken skin.

Do Not Use

Do not use if you are hypersensitive to poison ivy (Rhus tox) or any other ingredients in this product.Breast-feeding women should not apply to breast area.

Stop Use

Stop use and ask a doctor if skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and then occur again within a few days.These could be signs of a serious condition.

Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out Of Reach Of Children.

Keep out of reach of children.

Overdose

If swallowed, seek medical help or contact a Poison Control Center immediately.

* Please review the disclaimer below.