The following Structured Product Label (SPL) was submitted to the FDA by Nutritional Specialties, Inc. for the product Cold Sore Formula (NDC 83027-0007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, purpose:, warnings:, keep out of reach of children:, directions:, indications:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Dulcamara 3X, Glycyrrhiza Glabra 3X, Ranunculus Bulbosus 3X, Rhus Tox 5X, Natrum Muriaticum 6X, 30X, Fagopyrum Esculentum 8X, Natrum Muriaticum 12X, Aconitum Napellus 15X, 30X, 60X, 200X, Cytomegalovirus Nosode 15X, 30X, 60X, 200X, Herpes Simplex I and II Nosode 18X, 30X, 60X, 200X, Sepia 30X, Epstein-Barr Virus Nosode 15C, 30C, 60C, 200C, Herpes Zoster Nosode 18C, 30C, 60C, 200C, Adenoviren Nosode 20C, 30C, 60C, 200C.
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.
Professional Use Only
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
In case of overdose, get medical help or contact a Poison Control Center right away.
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.
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.
Alcohol USP 20%, Purified Water USP.
MANUFACTURED EXCLUSIVELY FOR
NUTRITIONAL SPECIALTIES, INC.
PO BOX 97227
PITTSBURG, PA 15229
www.phpltd.com
Professional
Health Products
HOMEOPATHIC
NDC 83027-0007-1
COLD SORE
FORMULA
2 FL. OZ (60 ml)
* Please review the disclaimer below.
