NDC 0360-4202 Smiles Prid Salve

Echinacea Angustifolia, Calendula Officinalis Flowering Top, Silicon Dioxide, Ichthammol, Phenol, Calcium Sulfide, Sulfur And Arnica Montana Flower

NDC Product Code 0360-4202

NDC Code: 0360-4202

Proprietary Name: Smiles Prid Salve 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: Echinacea Angustifolia, Calendula Officinalis Flowering Top, Silicon Dioxide, Ichthammol, Phenol, Calcium Sulfide, Sulfur And Arnica Montana Flower 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

  • 0360 - Standard Homeopathic Company

NDC 0360-4202-01

Package Description: 1 CAN in 1 CARTON > 18 SALVE in 1 CAN

NDC Product Information

Smiles Prid Salve with NDC 0360-4202 is a a human over the counter drug product labeled by Standard Homeopathic Company. The generic name of Smiles Prid Salve is echinacea angustifolia, calendula officinalis flowering top, silicon dioxide, ichthammol, phenol, calcium sulfide, sulfur and arnica montana flower. The product's dosage form is salve and is administered via topical form.

Labeler Name: Standard Homeopathic Company

Dosage Form: Salve - A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster).

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.

Smiles Prid Salve 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.

  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/1
  • SULFUR 12 [hp_X]/1
  • CALCIUM SULFIDE 12 [hp_X]/1
  • SILICON DIOXIDE 12 [hp_X]/1
  • CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/1
  • PHENOL 2 [hp_X]/1
  • ICHTHAMMOL 2 [hp_X]/1
  • ARNICA MONTANA FLOWER 3 [hp_X]/1

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)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ROSIN (UNII: 88S87KL877)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)

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: Standard Homeopathic Company
Labeler Code: 0360
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: 06-01-2019 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: 12-31-2020 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.

Smiles Prid Salve Product Label Images

Smiles Prid Salve 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:

Arnica 3X HPUS, Calendula 3X HPUS, Carbolicum Acidum 2X HPUS, Echinacea Ang 3X HPUS, Hepar Sulph Calc 12X HPUS, Ichthammol 2X HPUS, Silicea 12X HPUS, Sulphur 12X HPUS.

Uses:

Temporary topical relief of pain and irritation associated with boils, minor skin eruptions and redness. Also aids in relieving the discomfort of minor skin irritations, superficial cuts and scratches.

Other

If symptoms persist for more than a week or worsen, or if fever occurs, contact a licensed health care professional.

Do not use on open wounds.

SHC may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

For external use only. Avoid contact with eyes.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, contact a medical professional or contact a Poison Control Center.

Directions:

Wash affected area with hot water, dry and apply PRID
® twice daily on clean bandage or gauze. Do not squeeze or pressure irritated skin area. After irritation subsides, repeatapplication once a day for several days. Children under two years, consult physician.

Inactive Ingredients:

Beeswax, Ethyl Alcohol, Methylparaben,Petrolatum, Propylparaben, Puried Water, Stearyl Alcohol, Wood Rosin.

Otc - Questions

(800) 624-9659

Otc - Purpose

Temporary topical relief of pain and irritation associated with boils, minor skin eruptions and redness. Also aids in relieving the discomfort of minor skin irritations, superficial cuts and scratches.

* Please review the disclaimer below.