COLD SORE FREE (sambucus nigra flower echinacea angustifolia calendula officinalis flower pine needle oil- pinus sylvestris thuja occidentalis root salve

COLD SORE FREE by

Drug Labeling and Warnings

COLD SORE FREE by is a Homeopathic medication manufactured, distributed, or labeled by PUREMEDY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

ORGANIC SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

ORGANIC ECHINACEA ANGUSTIFOLIA (2X) HPUS

ORGANIC CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)

PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

THUJA OCCIDENT (6X) HPUS

PURPOSE

PROPERTIES

ANTI-INFLAMMATORY

ANTI-VIRAL

SKIN PROTECTANT

SKIN PROTECTANT

RELIEF FOR SKIN ERUPTIONS OR BURNING PAIN

INDICATIONS & USAGE

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH HERPETIC OUTBREAKS, COLD SORES AND CANKER SORES. USE ORALLY OR GENITALLY.

DOSAGE & ADMINISTRATION

DIRECTIONS: APPLY TO AFFECTED AREA 3-8 TIMES PER DAY AS NEEDED. MAY BE APPLIED GENITALLY. ALSO APPLY DAILY AS A PREVENTIVE MEASURE.

INACTIVE INGREDIENT

OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, BALSAM FIR, WILD HARVESTED DRAGONS BLOOD (SANGRE DE GRADO).

WARNINGS

WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

OTHER SAFETY INFORMATION

STORE IN A COOL DRY PLACE OR REFRIGERATE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD SORE FREE 
sambucus nigra flower echinacea angustifolia calendula officinalis flower pine needle oil (pinus sylvestris) thuja occidentalis root salve

Product 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

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
COASTAL CONTRACT PACKAGING, INC.		137341611	manufacture(52810-301)