Label: ANTI-ITCH EXTRA STRENGTH- calendula officinalis flowering top, hypericum perforatum whole, and sodium chloride solution/ drops

  • 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 August 6, 2020

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    *
    USDA Certified Organic
    Calendula* 8XFor Stinging, Cutting Pain, Skin Healing Agent
    Hypericum perforatum* 8XFor Insect Wounds, Mild Skin Infections
    Natrum 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.

    Keep out of reach of children.

    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 place
    • store upright
    • tighten cap after use to prevent oxidation
  • Inactive ingredients

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

  • Questions or comments?

    Call us at 1-877-975-3797 or visit our website www.forcesofnaturemedicine.com

  • SPL UNCLASSIFIED SECTION

    Manufactured & Distributed by Forces of Nature, Inc
    21787 8th St East #3A Sonoma, CA 95476 USA

  • PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton

    Homeopathic
    NDC #51393-4016-4

    FORCES OF NATURE

    Anti-Itch

    ORGANIC PLANT MEDICINE

    EXTRA STRENGTH

    Intensive Roll On Relief For:

    • Insect Bites & Poison Ivy
    • Skin Irritation & Rashes
    • Itching & Redness

    Calendula
    Officinalis

    USDA
    ORGANIC

    NON
    GMO
    Project
    VERIFIED
    nongmoproject.org

    4 ml (.14 FL OZ)

    PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH   EXTRA STRENGTH
    calendula officinalis flowering top, hypericum perforatum whole, and sodium chloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-4016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP8 [hp_X]  in 100 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM WHOLE - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE8 [hp_X]  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE8 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sesame Oil (UNII: QX10HYY4QV)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Palmarosa Oil (UNII: 0J3G3O53ST)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-4016-41 in 1 CARTON09/01/2020
    14 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC09/01/2020
    Labeler - Forces of Nature (050169130)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!