MedPath

Cold Sore Treatment

Cold Sore Treatment Extra Strength

Approved
Approval ID

0a5d32dc-c0e7-404e-85f2-6c3a338560ba

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 22, 2025

Manufacturers
FDA

Forces of Nature

DUNS: 050169130

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

echinacea angustifolia whole, sodium chloride, thuja occidentalis leafy twig, and calendula officinalis flowering top

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51393-5013
Product Classification
G
Generic Name
echinacea angustifolia whole, sodium chloride, thuja occidentalis leafy twig, and calendula officinalis flowering top
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 22, 2025
FDA Product Classification

INGREDIENTS (11)

ECHINACEA ANGUSTIFOLIA WHOLEActive
Quantity: 10 [hp_X] in 100 mL
Code: VB06AV5US8
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 10 [hp_X] in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 10 [hp_X] in 100 mL
Code: 1NT28V9397
Classification: ACTIB
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 10 [hp_X] in 100 mL
Code: 18E7415PXQ
Classification: ACTIB
EUCALYPTUS RADIATA FLOWERING TOP OILInactive
Code: C7YKX126BI
Classification: IACT
Lavandin OilInactive
Code: 9RES347CKG
Classification: IACT
WEST INDIAN LEMONGRASS OILInactive
Code: 5BIA40E9ED
Classification: IACT
Palmarosa OilInactive
Code: 0J3G3O53ST
Classification: IACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)Inactive
Code: 5EXL5H740Y
Classification: IACT
GERANIUM OIL, ALGERIAN TYPEInactive
Code: 5Q1I94P4WG
Classification: IACT
Tea Tree OilInactive
Code: VIF565UC2G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/22/2025

PRINCIPAL DISPLAY PANEL - 11 ml Bottle Carton

HOMEOPATHIC

NDC #51393-5013-1

FORCES OF
NATURE®
TRUSTED PLANT REMEDIES

Cold Sore
Treatment

EXTRA STRENGTH

RELIEVES PAIN & ITCHING FAST
with Echinacea & Northern White Cedar

  • Calms redness & swelling
  • Reduces tingling & burning
  • Helps repair skin

NON
GMO
Project
VERIFIED
nongmoproject.org

USDA
ORGANIC

11 ml (0.37 FL OZ)

Principal Display Panel - 11 ml Bottle Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/22/2025

Uses

this product is intended to treat symptoms of oral herpes simplex 1 or 2 after diagnosis by physician. Herpes is a viral infection. Symptoms:

  • Rashes
  • Blisters
  • Redness
  • Pain

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/22/2025

Manufactured by: Forces of Nature, Inc.
21787 8th St East, Sonoma, CA 95476

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/22/2025

Active ingredients

Purpose

  • Certified Organic

Echinacea Angustifolia* 10X

Relief from Skin Irritation

Natrum Muriaticum 10X

Treats Oral Herpes, Painful Skin Eruptions

Thuja Occidentalis* 10X

Relief for Skin Eruptions, Buming Pain

Calendula Officinalis* 10X

Promotes Healthy Skin and Healing

WARNINGS SECTION

LOINC: 34071-1Updated: 8/22/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/22/2025

Directions

Shake well before use. For best results, use at the first sign of symptoms or when you feel a cold sore starting. Roll a small amount over the problem area up to 4 times per day during an outbreak. Apply to the soles of feet for systemic support.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/22/2025

Other information

  • Store in a cool, dark place
  • Store upright
  • Tighten cap after use to prevent oxidation

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/22/2025

Inactive ingredients

Eucalyptus Oil*, Lavandin Oil*, Lemongrass Oil*, Palmarosa Oil*, Pine Oil*, Rose Geranium Oil*, Tea Tree Oil*

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/22/2025

Questions?

1-877-975-3797

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