The following Structured Product Label (SPL) was submitted to the FDA by Nutritional Specialties, Inc. for the product Cold Sore Formula (NDC 83027-0303). 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:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each spray) 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 & II Nosode 20X, 30X, 60X, 200X, Herpes Zoster Nosode 18C, 30C, 60C, 200C, Natrum Hypochlorous 12X, Natrum Muriaticum 6X, 30X, Ranunculus Bulbosus 3X, Rhus Tox 5X, Sepia 30X.
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 & II Nosode - Assists in Relieving Symptoms of Cold Sores,† Herpes Zoster Nosode - Assists in Relieving Symptoms of Cold Sores,† Natrum Hypochlorous – 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.
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.
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 area 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.
Alcohol USP 20%, Purified Water USP.
MANUFACTURED EXCLUSIVELY FOR
NUTRITIONAL SPECIALTIES, INC.
PO BOX 97227
PITTSBURG, PA 15229
www.phpltd.com
1-800-245-1313
Professional
Health Products
HOMEOPATHIC
NDC 83027-0303-1
COLD SORE
FORMULA
2 FL. OZ (60 ml)
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