TENDON RESCUE- bryonia, ruta graveolens, bellis perennis, argentum metallicum gel

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

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Active ingredient:
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B), RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S), BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY), SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)
Available from:
Peaceful Mountain
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of symptoms of tendon and soft tissue discomfort. For temporary relief of symptoms of tendon and soft tissue discomfort.
Authorization status:
unapproved homeopathic
Authorization number:
43846-0001-1

TENDON RESCUE- bryonia, ruta graveolens, bellis perennis, argentum metallicum gel

Peaceful Mountain

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 Facts:

ACTIVE INGREDIENTS:

Bryonia 3X, 12X, Ruta Graveolens 3X, 12X, Bellis Perennis 6X, Argentum Metallicum 30X.

INDICATIONS:

For temporary relief of symptoms of tendon and soft tissue discomfort.

WARNINGS:

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

right away.

When using this product Do not get into eyes

Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days

DIRECTIONS:

Apply at least 3 times daily over the affected area. Consult a physician for use in children under 12

years of age.

INACTIVE INGREDIENTS:

Aloe Vera Concentrate, Arnica Montana Flower, Carbomer, Symphytum Officinale Leaf, Edetate

Disodium, Oregano, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic

Acid, Potassium Sorbate, Purfied Water, Rosmarinus Officinalis (leaf), Sodium Hydroxide Solution,

Ascorbic Acid, Vitamin E Oil.

KEEP OUT OF REACH OF CHILDREN:

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS:

For temporary relief of symptoms of tendon and soft tissue discomfort.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

patent pending

PACKAGE LABEL DISPLAY

peaceful mountain

THE HEIGHT OF HEALTH

tendon rescue

homeopathic gel

paraben-free

organic and wild-crafted herbs

formulated in boulder, co

Net wt. 4 lbs. (64 oz.)(1.8 kg)

TENDON RESCUE

bryonia, ruta graveolens, bellis perennis, argentum metallicum gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 46 -0 0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT - UNII:T7J0 46 YI2B)

BRYONIA ALBA ROOT

3 [hp_X]

in 1 g

RUTA GRAVEO LENS FLO WERING TO P (UNII: N9 4C2U58 7S) (RUTA GRAVEOLENS

FLOWERING TOP - UNII:N9 4C2U58 7S)

RUTA GRAVEOLENS

FLOWERING TOP

3 [hp_X]

in 1 g

6 [hp_X]

Peaceful Mountain

BELLIS PERENNIS (UNII: 2HU33I0 3UY) (BELLIS PERENNIS - UNII:2HU33I0 3UY)

BELLIS PERENNIS

6 [hp_X]

in 1 g

SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)

SILVER

30 [hp_X]

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

CO MFREY LEAF (UNII: DG4F8 T8 39 X)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

O REGANO (UNII: 0 E5AT8 T16 U)

PO LYETHYLENE GLYCO L 150 0 (UNII: 1212Z7S33A)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PO LYETHYLENE GLYCO L 7 0 0 (UNII: 76 26 78 AC5R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

WATER (UNII: 0 59 QF0 KO0 R)

RO SEMARY (UNII: IJ6 7X351P9 )

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:438 46 -0 0 0 1-1

18 14 g in 1 JUG

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

0 3/21/20 13

Labeler -

Peaceful Mountain (078430707)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(438 46 -0 0 0 1) , api manufacture(438 46 -0 0 0 1) , label(438 46 -0 0 0 1) ,

pa c k(438 46 -0 0 0 1)

Revised: 2/2015

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