NDC 51393-4016 Anti-itch Extra Strength

Calendula Officinalis Flowering Top, Hypericum Perforatum Whole, And Sodium Chloride

NDC Product Code 51393-4016

NDC CODE: 51393-4016

Proprietary Name: Anti-itch Extra Strength 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: Calendula Officinalis Flowering Top, Hypericum Perforatum Whole, And Sodium Chloride 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

  • 51393 - Forces Of Nature

NDC 51393-4016-4

Package Description: 1 BOTTLE, DISPENSING in 1 CARTON > 4 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Anti-itch Extra Strength with NDC 51393-4016 is a a human over the counter drug product labeled by Forces Of Nature. The generic name of Anti-itch Extra Strength is calendula officinalis flowering top, hypericum perforatum whole, and sodium chloride. The product's dosage form is solution/ drops and is administered via topical form.

Labeler Name: Forces Of Nature

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Anti-itch Extra Strength 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.

  • CALENDULA OFFICINALIS FLOWERING TOP 8 [hp_X]/100mL
  • HYPERICUM PERFORATUM WHOLE 8 [hp_X]/100mL
  • SODIUM CHLORIDE 8 [hp_X]/100mL

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.

  • SESAME OIL (UNII: QX10HYY4QV)
  • LAVANDIN OIL (UNII: 9RES347CKG)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PALMAROSA OIL (UNII: 0J3G3O53ST)

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.
  • 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: Forces Of Nature
Labeler Code: 51393
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: 09-01-2020 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: 12-31-2021 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.

Anti-itch Extra Strength Product Label Images

Anti-itch Extra Strength 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

Other

Drug Facts

Manufactured & Distributed by Forces of Nature, Inc21787 8th St East #3A Sonoma, CA 95476 USA

Otc - Purpose

Active ingredientsPurposeCalendulaUSDA Certified Organic 8XFor Stinging, Cutting Pain, Skin Healing AgentHypericum perforatum 8XFor Insect Wounds, Mild Skin InfectionsNatrum muriaticum 8XFor Itchy Skin

Uses

To provide relief from skin infections and reduce itching.

Warnings

For external use only. Some individuals may be sensitive to essential oils. Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs. Stop use and consult a doctor if condition worsens. Not for use on children under the age of 2 without physician direction.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. If accidental ingestion and adverse reaction occurs, get medical help or contact a Poison Control Center.

Directions

Shake well before use. Roll product over affected area. Gently rub into the skin. Apply three times per day.

Other Information

  • Keep in cool dark placestore uprighttighten cap after use to prevent oxidation

Inactive Ingredients

Sesame Oil, Lavandin Oil, Tea Tree Oil, Palmarosa Oil

* Please review the disclaimer below.