NDC 51393-7611 Athletes Foot/jock Itch Control

Centella Asiatica, Silicon Dioxide, And Thuja Occidentalis Root

NDC Product Code 51393-7611

NDC 51393-7611-1

Package Description: 11 mL in 1 BOTTLE, DISPENSING

NDC 51393-7611-2

Package Description: 33 mL in 1 BOTTLE, DISPENSING

NDC 51393-7611-4

Package Description: 4 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Athletes Foot/jock Itch Control with NDC 51393-7611 is a a human over the counter drug product labeled by Forces Of Nature. The generic name of Athletes Foot/jock Itch Control is centella asiatica, silicon dioxide, and thuja occidentalis root. The product's dosage form is solution/ drops and is administered via topical form.

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.

Athletes Foot/jock Itch Control 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.

  • TEA TREE OIL (UNII: VIF565UC2G)
  • GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
  • CLOVE OIL (UNII: 578389D6D0)
  • SESAME OIL (UNII: QX10HYY4QV)

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: 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: 12-01-2011 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 - 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.

Athletes Foot/jock Itch Control Product Label Images

Athletes Foot/jock Itch Control 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

CONTROL DRUG FACTS

Manufactured & Distributed byFORCES OF NATURE®21787 8th St East #3A Sonoma, CA 95476 USA

Otc - Purpose

Active IngredientsHydrocotyle AsiaticaUSDA Certified Organic 30C - Remedy for Itchy SkinSilicea 8X - Anti-Fungal RemedyThuja Occidentalis 30C - Remedy for Fungal Related Ailments

Also Contains

Sesame Oil, Rose Geranium Oil, Tea Tree Oil, Clove Oil

Indications

For the treatment of athlete's foot (tinea pedis) and jock itch (tinea cruris). Relieves burning feet associated with athlete's foot and relieves the itching, burning, and irritation associated with jock itch.

Directions

Shake well before use. Clean the affected area and dry thoroughly. Apply a thin layer of product over the affected area 3 times daily. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. For jock itch, use daily for 2 weeks. Not to be used for diaper rash. If condition persists longer, consult a doctor. For children under 2 years of age, consult a doctor before use.

Warnings

Some individuals may be sensitive to essential oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin. For external use only. If accidental ingestion of more than several drops, and adverse reaction occurs, get medical help or contact a Poison Control Center. Do not apply to the eyes. If you are pregnant or breast-feeding, ask a health professional before use. Not for use on children under the age of 2 without physician direction.

Otc - Keep Out Of Reach Of Children

Keep all medicines out of the reach of children.

Otc - Stop Use

Stop use and consult a doctor if condition worsens, or consult a doctor if symptoms show no improvement after 7 days.

Tips For Use

  • The amount of time to eliminate a fungal infection can range from 1-2 weeks for mild cases, up to several months for moderate to severe infections. The main factors that determine how long the treatment will take include:The location of the fungus – Athlete's foot typically has a longer healing time than jock itch as shoes and socks provide a warm/wet environment for the fungus to live.The strength of the individual's immune system - A strong immune system will likely shorten the healing process.How long the fungus has been there - The longer the symptom has been present the longer the treatment will take.Your application schedule - Athlete's Foot/Jock Itch Control should be applied at least 2-3 times every day.The environment in which the fungus lives - Fungus thrives in warm/wet environments and allowing the area to dry out between applications can reduce the time it takes to remove the infection.

* Please review the disclaimer below.