FIRST AID- sambucus nigra flower calendula officinalis flower pine needle oil (pinus sylvestris) salve

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)
Available from:
PUREMEDY
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
PROPERTIES SKIN PROTECTANT SKIN PROTECTANT SKIN PROTECTANT USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH MINOR SKIN IRRITATIONS, BOILS, CUTS, BURNS, AND OTHER FIRST AID NEEDS.
Authorization status:
unapproved homeopathic
Authorization number:
52810-202-11

FIRST AID- sambucus nigra flower calendula officinalis flower pine needle oil (pinus

sylvestris) 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.

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ACTIVE INGREDIENTS

ORGANIC SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

ORGANIC CALENDULA OFFICINALIS (2X) HPUS (MARIGOLD)

PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

PROPERTIES

SKIN PROTECTANT

SKIN PROTECTANT

SKIN PROTECTANT

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH MINOR SKIN IRRITATIONS, BOILS,

CUTS, BURNS, AND OTHER FIRST AID NEEDS.

DIRECTIONS: APPLY TO AFFECTED AREA 2-4 TIMES PER DAY OR AS NEEDED. COVER

WITH A BANDAID OR TELFA BANDAGE IF NECESSARY. DO NOT DRESS WITH GAUZA.

OTHER INGREDIENTS: ORGANIC OLIVE OIL, SAFFLOWER OIL, ORGANIC BEESWAX.

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.

CUSTOMER SERVICE 310-526-6108

FIRST AID

sambucus nigra flower calendula officinalis flower pine needle oil (pinus sylvestris) salve

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:528 10 -20 2

Route of Administration

TOPICAL

PUREMEDY

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

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)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:528 10 -20 2-11

30 mL in 1 JAR

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

COASTAL CONTRACT PACKAGING, INC.

1373416 11

ma nufa c ture (528 10 -20 2)

Revised: 10/2012

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