Label: COLD SORE FORMULA- dulcamara, glycyrrhiza glabra, ranunculus bulbosus, rhus tox, natrum muriaticum, fagopyrum esculentum, natrum muriaticum, aconitum napellus, cytomegalovirus nosode, herpes simplex i and ii nosode, sepia, epstein barr virus nosode, herpes zoster nosode, adenoviren nosode spray
- NDC Code(s): 83027-0007-1
- Packager: Nutritional Specialties, Inc.
- 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 March 30, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENTS:
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.
- PURPOSE:
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WARNINGS:
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
- KEEP OUT OF REACH OF CHILDREN:
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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.
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
COLD SORE FORMULA
dulcamara, glycyrrhiza glabra, ranunculus bulbosus, rhus tox, natrum muriaticum, fagopyrum esculentum, natrum muriaticum, aconitum napellus, cytomegalovirus nosode, herpes simplex i and ii nosode, sepia, epstein barr virus nosode, herpes zoster nosode, adenoviren nosode sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83027-0007 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 3 [hp_X] in 1 mL GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA 3 [hp_X] in 1 mL RANUNCULUS BULBOSUS WHOLE (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS WHOLE 3 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 5 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL FAGOPYRUM ESCULENTUM WHOLE (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM WHOLE 8 [hp_X] in 1 mL SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N) SODIUM HYPOCHLORITE 12 [hp_X] in 1 mL ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 15 [hp_X] in 1 mL HUMAN HERPESVIRUS 5 (UNII: 7COI029E6K) (HUMAN HERPESVIRUS 5 - UNII:7COI029E6K) HUMAN HERPESVIRUS 5 15 [hp_X] in 1 mL HUMAN HERPESVIRUS 1 (UNII: 22G38P19RL) (HUMAN HERPESVIRUS 1 - UNII:22G38P19RL) HUMAN HERPESVIRUS 1 18 [hp_X] in 1 mL HUMAN HERPESVIRUS 2 (UNII: 74J6DNH49U) (HUMAN HERPESVIRUS 2 - UNII:74J6DNH49U) HUMAN HERPESVIRUS 2 18 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 30 [hp_X] in 1 mL HUMAN HERPESVIRUS 4 (UNII: 2A26YW7PNX) (HUMAN HERPESVIRUS 4 - UNII:2A26YW7PNX) HUMAN HERPESVIRUS 4 15 [hp_C] in 1 mL HUMAN HERPESVIRUS 3 (UNII: 9885M7D6JP) (HUMAN HERPESVIRUS 3 - UNII:9885M7D6JP) HUMAN HERPESVIRUS 3 18 [hp_C] in 1 mL HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN (UNII: FKD3DUK39I) (HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 - UNII:FKD3DUK39I) HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN 20 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83027-0007-1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/30/2023 Labeler - Nutritional Specialties, Inc. (032744609)
