COLD SORE FREE (sambucus nigra flower echinacea angustifolia calendula officinalis flower pine needle oil- pinus sylvestris thuj

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8), SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T), CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD), PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) (PINE NEEDLE OIL (PINUS SYLVESTRIS) - UNII:5EXL5H740Y), THUJA OCCIDENTALIS ROOT (UNII: 12958C0BR3) (THUJA OCCIDENTALIS ROOT - UNII:12958C0BR3)
Available from:
PUREMEDY
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
PROPERTIES ANTI-INFLAMMATORY ANTI-VIRAL SKIN PROTECTANT SKIN PROTECTANT RELIEF FOR SKIN ERUPTIONS OR BURNING PAIN USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH HERPETIC OUTBREAKS, COLD SORES AND CANKER SORES. USE ORALLY OR GENITALLY.
Authorization status:
unapproved homeopathic
Authorization number:
52810-301-11

COLD SORE FREE- sambucus nigra flower echinacea angustifolia calendula officinalis flower

pine needle oil (pinus sylvestris) thuja occidentalis root salve

PUREMEDY

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.

----------

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

PROPERTIES

ANTI-INFLAMMATORY

ANTI-VIRAL

SKIN PROTECTANT

SKIN PROTECTANT

RELIEF FOR SKIN ERUPTIONS OR BURNING PAIN

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH HERPETIC OUTBREAKS, COLD SORES

AND CANKER SORES. USE ORALLY OR GENITALLY.

DIRECTIONS: APPLY TO AFFECTED AREA 3-8 TIMES PER DAY AS NEEDED. MAY BE

APPLIED GENITALLY. ALSO APPLY DAILY AS A PREVENTIVE MEASURE.

OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC

BEESWAX, BALSAM FIR, WILD HARVESTED DRAGONS BLOOD (SANGRE DE GRADO).

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.

STORE IN A COOL DRY PLACE OR REFRIGERATE

COLD SORE FREE

sambucus nigra flower echinacea angustifolia calendula officinalis flower pine needle oil (pinus sylvestris) thuja

occidentalis root salve

PUREMEDY

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:528 10 -30 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 ) (ECHINACEA ANGUSTIFOLIA -

UNII:VB0 6 AV5US8 )

ECHINACEA

ANGUSTIFOLIA

2 [hp_X]

in 10 0 mL

SAMBUCUS NIGRA FLO WER (UNII: 0 7V4DX0 9 4T) (SAMBUCUS NIGRA FLOWER -

UNII:0 7V4DX0 9 4T)

SAMBUCUS NIGRA

FLOWER

1 [hp_X]

in 10 0 mL

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD) (CALENDULA

OFFICINALIS FLOWER - UNII:P0 M7O4Y7YD)

CALENDULA OFFICINALIS

FLOWER

1 [hp_X]

in 10 0 mL

PINE NEEDLE O IL ( PINUS SYLVESTRIS) (UNII: 5EXL5H740 Y) (PINE NEEDLE OIL

(PINUS SYLVESTRIS) - UNII:5EXL5H740 Y)

PINE NEEDLE OIL (PINUS

SYLVESTRIS)

1 [hp_X]

in 10 0 mL

THUJA O CCIDENTALIS RO O T (UNII: 129 58 C0 BR3) (THUJA OCCIDENTALIS ROOT -

UNII:129 58 C0 BR3)

THUJA OCCIDENTALIS

ROOT

6 [hp_X]

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

O LIVE O IL (UNII: 6 UYK2W1W1E)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

ABIES BALSAMEA LEAF O IL (UNII: 2FGT9 T2SQC)

DRAGO N'S BLO O D (UNII: M3YJ2C28 IC)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:528 10 -30 1-11

30 mL in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

10 /18 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

10 /18 /20 12

Labeler -

PUREMEDY (003552251)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

PUREMEDY

0 0 3552251

ma nufa c ture (528 10 -30 1)

Revised: 3/2020

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