Label: ATHLETES FOOT/JOCK ITCH CONTROL- centella asiatica, silicon dioxide, and thuja occidentalis root solution/ drops

  • NDC Code(s): 51393-7611-1, 51393-7611-2, 51393-7611-4
  • Packager: Forces of Nature
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 24, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    CONTROL DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients
    *
    USDA Certified Organic
    Hydrocotyle Asiatica* 30C - Remedy for Itchy Skin
    Silicea* 8X - Anti-Fungal Remedy
    Thuja 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.

    Keep all medicines out of the reach of children.

    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.
  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton

    Homeopathic
    NDC #51393-7611-4

    FORCES OF NATURE®
    CERTIFIED ORGANIC MEDICINE

    Athlete's Foot
    ROLLERBALL APPLICATOR

    Anti - Fungal Medicine

    • Quickly Relieves Itching & Burning
    • Deep Penetrating Anti-Fungal Action
    • Soothes and Promotes Healthy Skin
    • Fights both Athletes Foot
      & Jock Itch
    • Rare Essential Oils
      by Elite Growers
      from Across
      the Planet

    Hydrocotyle
    Asiatica

    USDA
    ORGANIC

    .14 OZ / 4 ml Rollerball

    PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT/JOCK ITCH   CONTROL
    centella asiatica, silicon dioxide, and thuja occidentalis root solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-7611
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Centella Asiatica Whole (UNII: 7M867G6T1U) (Centella Asiatica Whole - UNII:7M867G6T1U) Centella Asiatica Whole30 [hp_C]  in 1000 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide8 [hp_X]  in 1000 mL
    Thuja Occidentalis Root (UNII: 12958C0BR3) (Thuja Occidentalis Root - UNII:12958C0BR3) Thuja Occidentalis Root30 [hp_C]  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Tea Tree Oil (UNII: VIF565UC2G)  
    Geranium Oil, Algerian Type (UNII: 5Q1I94P4WG)  
    Clove Oil (UNII: 578389D6D0)  
    Sesame Oil (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-7611-44 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/15/2017
    2NDC:51393-7611-111 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2011
    3NDC:51393-7611-233 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/01/2011
    Labeler - Forces of Nature (050169130)