Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID f4e7e469-baaf-4c61-af44-80b0832eadf0
Route
ORAL
Published
Effective Date 2024-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Solanum Dulcamara Top (3 [hp_X]) Glycyrrhiza Glabra (5 [hp_X]) Ranunculus Bulbosus (6 [hp_X]) Toxicodendron Pubescens Leaf (8 [hp_X]) Chloride Ion (12 [hp_X]) Fagopyrum Esculentum (15 [hp_X]) Hypochlorite Ion (18 [hp_X]) Aconitum Napellus (30 [hp_X]) Human Herpesvirus 5 (15 [hp_C]) Human Herpesvirus 1 (18 [hp_C]) Human Herpesvirus 2 (20 [hp_C]) Sepia Officinalis Juice Human Herpesvirus 4 Human Herpesvirus 3 Human Adenovirus E Serotype 4 Strain Cl-68578
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-03-30
Description

(in each teaspoon) Aconitum Napellus 15X, 30X, 60X, 200X, Adenoviren Nosode 20C, 30C, 60C, 200C, Cytomegalovirus Nosode 15X, 30X, 60X, 200X, Dulcamara 3X, Epstein-Barr Virus Nosode 15C, 30C, 60C, 200C, Fagopyrum Esculentum 8X, Glycyrrhiza Glabra 3X, Herpes Simplex I and II Nosode 18X, 30X, 60X, 200X, Herpes Zoster Nosode 18C, 30C, 60C, 200C, Natrum Hypochlorosum 12X, Natrum Muriaticum 6X, 30X, Ranunculus Bulbosus 3X, Rhus Tox 5X, Sepia 30X.

Purpose

Aconitum Napellus – Assists in Relieving Pain Associated with Cold Sores,† Adenoviren Nosode - Assists in Relieving Symptoms of Cold Sores,† Cytomegalovirus Nosode - Assists in Relieving Symptoms of Cold Sores,† Dulcamara - Assists in Relieving Symptoms of Cold Sores,† Epstein-Barr Virus Nosode - Assists in Relieving Symptoms of Cold Sores,† Fagopyrum Esculentum – Assists in Relieving the Pustules and Itching Associated with Cold Sores,† Glycyrrhiza Glabra - Assists in Relieving Symptoms of Cold Sores,† Herpes Simplex I and II Nosode - Assists in Relieving Symptoms of Cold Sores,† Herpes Zoster Nosode - Assists in Relieving Symptoms of Cold Sores,† Natrum Hypochlorosum – Assists in Relieving the Itching Associated with Cold Sores,† Natrum Muriaticum – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Ranunculus Bulbosus – Assists in Relieving the Pain, Burning and Itching Associated with Cold Sores,† Rhus Tox – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Sepia – Assists in Relieving Symptoms of Cold Sores. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Medication Information

Purpose

Aconitum Napellus – Assists in Relieving Pain Associated with Cold Sores,† Adenoviren Nosode - Assists in Relieving Symptoms of Cold Sores,† Cytomegalovirus Nosode - Assists in Relieving Symptoms of Cold Sores,† Dulcamara - Assists in Relieving Symptoms of Cold Sores,† Epstein-Barr Virus Nosode - Assists in Relieving Symptoms of Cold Sores,† Fagopyrum Esculentum – Assists in Relieving the Pustules and Itching Associated with Cold Sores,† Glycyrrhiza Glabra - Assists in Relieving Symptoms of Cold Sores,† Herpes Simplex I and II Nosode - Assists in Relieving Symptoms of Cold Sores,† Herpes Zoster Nosode - Assists in Relieving Symptoms of Cold Sores,† Natrum Hypochlorosum – Assists in Relieving the Itching Associated with Cold Sores,† Natrum Muriaticum – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Ranunculus Bulbosus – Assists in Relieving the Pain, Burning and Itching Associated with Cold Sores,† Rhus Tox – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Sepia – Assists in Relieving Symptoms of Cold Sores. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each teaspoon) Aconitum Napellus 15X, 30X, 60X, 200X, Adenoviren Nosode 20C, 30C, 60C, 200C, Cytomegalovirus Nosode 15X, 30X, 60X, 200X, Dulcamara 3X, Epstein-Barr Virus Nosode 15C, 30C, 60C, 200C, Fagopyrum Esculentum 8X, Glycyrrhiza Glabra 3X, Herpes Simplex I and II Nosode 18X, 30X, 60X, 200X, Herpes Zoster Nosode 18C, 30C, 60C, 200C, Natrum Hypochlorosum 12X, Natrum Muriaticum 6X, 30X, Ranunculus Bulbosus 3X, Rhus Tox 5X, Sepia 30X.

Uses:

Assists in relieving the symptoms of cold sores including

•blistering, •dry cracked skin, •pustules, and the •pain,

•burning, •itching associated with the same.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose:

Aconitum Napellus – Assists in Relieving Pain Associated with Cold Sores,† Adenoviren Nosode - Assists in Relieving Symptoms of Cold Sores,† Cytomegalovirus Nosode - Assists in Relieving Symptoms of Cold Sores,† Dulcamara - Assists in Relieving Symptoms of Cold Sores,† Epstein-Barr Virus Nosode - Assists in Relieving Symptoms of Cold Sores,† Fagopyrum Esculentum – Assists in Relieving the Pustules and Itching Associated with Cold Sores,† Glycyrrhiza Glabra - Assists in Relieving Symptoms of Cold Sores,† Herpes Simplex I and II Nosode - Assists in Relieving Symptoms of Cold Sores,† Herpes Zoster Nosode - Assists in Relieving Symptoms of Cold Sores,† Natrum Hypochlorosum – Assists in Relieving the Itching Associated with Cold Sores,† Natrum Muriaticum – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Ranunculus Bulbosus – Assists in Relieving the Pain, Burning and Itching Associated with Cold Sores,† Rhus Tox – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Sepia – Assists in Relieving Symptoms of Cold Sores.

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions:

• Adults: Acute 2 to 3 sprays orally every hour, up to 48 hours. Then 2 to 3 sprays three times per day. Chronic and maintenance 1 to 2 sprays       four times daily. Can be sprayed directly on afflicted areas in conjunction with oral use. Children under twelve one half adult dosage.

• Do not take within 15 minutes of consuming food, beverage or brushing teeth.

• Consult a physician for use in children under 12 years of age.

Active Ingredients:

(in each teaspoon) Aconitum Napellus 15X, 30X, 60X, 200X, Adenoviren Nosode 20C, 30C, 60C, 200C, Cytomegalovirus Nosode 15X, 30X, 60X, 200X, Dulcamara 3X, Epstein-Barr Virus Nosode 15C, 30C, 60C, 200C, Fagopyrum Esculentum 8X, Glycyrrhiza Glabra 3X, Herpes Simplex I and II Nosode 18X, 30X, 60X, 200X, Herpes Zoster Nosode 18C, 30C, 60C, 200C, Natrum Hypochlorosum 12X, Natrum Muriaticum 6X, 30X, Ranunculus Bulbosus 3X, Rhus Tox 5X, Sepia 30X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0007-1

COLD SORE 

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses: (USES:)

Assists in relieving the symptoms of cold sores including

•blistering, •dry cracked skin, •pustules, and the •pain,

•burning, •itching associated with the same.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose: (PURPOSE:)

Aconitum Napellus – Assists in Relieving Pain Associated with Cold Sores,† Adenoviren Nosode - Assists in Relieving Symptoms of Cold Sores,† Cytomegalovirus Nosode - Assists in Relieving Symptoms of Cold Sores,† Dulcamara - Assists in Relieving Symptoms of Cold Sores,† Epstein-Barr Virus Nosode - Assists in Relieving Symptoms of Cold Sores,† Fagopyrum Esculentum – Assists in Relieving the Pustules and Itching Associated with Cold Sores,† Glycyrrhiza Glabra - Assists in Relieving Symptoms of Cold Sores,† Herpes Simplex I and II Nosode - Assists in Relieving Symptoms of Cold Sores,† Herpes Zoster Nosode - Assists in Relieving Symptoms of Cold Sores,† Natrum Hypochlorosum – Assists in Relieving the Itching Associated with Cold Sores,† Natrum Muriaticum – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Ranunculus Bulbosus – Assists in Relieving the Pain, Burning and Itching Associated with Cold Sores,† Rhus Tox – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Sepia – Assists in Relieving Symptoms of Cold Sores.

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (DIRECTIONS:)

• Adults: Acute 2 to 3 sprays orally every hour, up to 48 hours. Then 2 to 3 sprays three times per day. Chronic and maintenance 1 to 2 sprays       four times daily. Can be sprayed directly on afflicted areas in conjunction with oral use. Children under twelve one half adult dosage.

• Do not take within 15 minutes of consuming food, beverage or brushing teeth.

• Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each teaspoon) Aconitum Napellus 15X, 30X, 60X, 200X, Adenoviren Nosode 20C, 30C, 60C, 200C, Cytomegalovirus Nosode 15X, 30X, 60X, 200X, Dulcamara 3X, Epstein-Barr Virus Nosode 15C, 30C, 60C, 200C, Fagopyrum Esculentum 8X, Glycyrrhiza Glabra 3X, Herpes Simplex I and II Nosode 18X, 30X, 60X, 200X, Herpes Zoster Nosode 18C, 30C, 60C, 200C, Natrum Hypochlorosum 12X, Natrum Muriaticum 6X, 30X, Ranunculus Bulbosus 3X, Rhus Tox 5X, Sepia 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0007-1

COLD SORE 

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:35.494973 · Updated: 2026-03-14T23:17:01.647677