ROSACEA FREE (pine needle oil- pinus sylvestris sambucus nigra flower calendula officinalis flower abies balsamea leaf oil echin

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

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Active ingredient:
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), ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC) (ABIES BALSAMEA LEAF OIL - UNII:2FGT9T2SQC), ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)
Available from:
PUREMEDY
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
PROPERTIES SKIN PROTECTANT ANTI-INFLAMMATORY SKIN PROTECTANT SKIN PROTECTANT MULTI-PURPOSE SKIN HEALING REMEDY USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED, INFLAMED OR AGING SKIN.
Authorization status:
unapproved homeopathic
Authorization number:
52810-602-11

ROSACEA FREE- pine needle oil (pinus sylvestris) sambucus nigra flower calendula officinalis

flower abies balsamea leaf oil echinacea angustifolia 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

PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

ORG. CALENDULA OFFICINALIS (2X) HPUS (MARIGOLD)

ABIES BALSAMEA (2X) HPUS (BALSAM FIR)

ECHINACEA ANGUSTIFOLIA (6X) HPUS

PROPERTIES

SKIN PROTECTANT

ANTI-INFLAMMATORY

SKIN PROTECTANT

SKIN PROTECTANT

MULTI-PURPOSE SKIN HEALING REMEDY

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED,

INFLAMED OR AGING SKIN.

DIRECTIONS: APPLY TO CLEAN, DRY AFFECTED AREA MORNING AND NIGHT, AS

NEEDED UNTIL CONDITION CLEARS. THEN APPLY NIGHTLY TO MAINTAIN HEALTHY

SKIN.

OTHER INGREDIENTS: ORGANIC BEESWAX, ORGANIC OLIVE OIL, ORGANIC ARGAN OIL,

ORGANIC SEA BUCKTHORN OIL

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. (* =

CERTIFIED ORGANIC INGREDIENTS)

KEEP OUT OF REACH OF CHILDREN.

CUSTOMER SERVICE 310-526-6108

STORE IN A COOL DRY PLACE OR REFRIGERATE

ROSACEA FREE

pine needle oil (pinus sylvestris) sambucus nigra flower calendula officinalis flower abies balsamea leaf oil

echinacea angustifolia salve

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:528 10 -6 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

UNII:0 7V4DX0 9 4T)

SAMBUCUS NIGRA

FLOWER

2 [hp_X]

in 10 0 mL

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

OFFICINALIS FLOWER - UNII:P0 M7O4Y7YD)

CALENDULA OFFICINALIS

FLOWER

2 [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

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

UNII:2FGT9 T2SQC)

ABIES BALSAMEA LEAF

2 [hp_X]

in 10 0 mL

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

UNII:VB0 6 AV5US8 )

ECHINACEA

ANGUSTIFOLIA

6 [hp_X]

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

O LIVE O IL (UNII: 6 UYK2W1W1E)

ARGAN O IL (UNII: 4V59 G5UW9 X)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

HIPPO PHAE RHAMNO IDES WHO LE (UNII: YAA7TG74X6 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:528 10 -6 0 2-11

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 -6 0 2)

PUREMEDY

Revised: 3/2020

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