Label: COLD SORE FREE (sambucus nigra flower echinacea angustifolia calendula officinalis flower pine needle oil- pinus sylvestris thuja occidentalis root salve
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Contains inactivated NDC Code(s)
NDC Code(s): 52810-301-11 - Packager: PUREMEDY
- Category: HUMAN OTC DRUG LABEL
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 December 19, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD SORE FREE
sambucus nigra flower echinacea angustifolia calendula officinalis flower pine needle oil (pinus sylvestris) thuja occidentalis root salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52810-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 2 [hp_X] in 100 mL SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER 1 [hp_X] in 100 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 100 mL PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) (PINE NEEDLE OIL (PINUS SYLVESTRIS) - UNII:5EXL5H740Y) PINE NEEDLE OIL (PINUS SYLVESTRIS) 1 [hp_X] in 100 mL THUJA OCCIDENTALIS ROOT (UNII: 12958C0BR3) (THUJA OCCIDENTALIS ROOT - UNII:12958C0BR3) THUJA OCCIDENTALIS ROOT 6 [hp_X] in 100 mL Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) SAFFLOWER OIL (UNII: 65UEH262IS) YELLOW WAX (UNII: 2ZA36H0S2V) ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC) DRAGON'S BLOOD (UNII: M3YJ2C28IC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52810-301-11 30 mL in 1 JAR; Type 0: Not a Combination Product 10/18/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/18/2012 Labeler - PUREMEDY (003552251) Establishment Name Address ID/FEI Business Operations PUREMEDY 003552251 manufacture(52810-301)