MUSCLE RESCUE- arnica montana, rhus toxicodendron, phytolacca decandra, pulsatilla, ruta graveolens gel

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

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Active ingredient:
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW), TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A), PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG), PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV), RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)
Available from:
Peaceful Mountain, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of minor symptoms of muscle aches, pain from overexertion, and injury. For temporary relief of minor symptoms of muscle aches, pain from overexertion, and injury.
Authorization status:
unapproved homeopathic
Authorization number:
43846-0035-1

MUSCLE RESCUE- arnica montana, rhus toxicodendron, phytolacca decandra, pulsatilla, ruta

graveolens gel

Peaceful Mountain, Inc.

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:

Arnica Montana 3X, Rhus Toxicodendron 3X, Phytolacca Decandra 12X, Pulsatilla 12X, Ruta

Graveolens 12X.

INDICATIONS:

For temporary relief of minor symptoms of muscle aches, pain from overexertion, and injury.

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 using and ask 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 10X Concentrate, Arnica Montana, Carbomer, Symphytum Officinale, Edetate Disodium,

Natural Plant Extract, PEG-33, PEG-8, PEG-14, Phenodroxyethanol, Caprylyl Glycol, Sorbic Acid,

Potassium Sorbate, Purified Water, Sodium Hydroxide, Vitamin C, Vitamin E Oil, White Willow, Witch

Hazel.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children.

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

right away.

INDICATIONS:

For temporary relief of minor symptoms of muscle aches, pain from overexertion, and injury.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE DISPLAY LABEL:

peaceful mountain

muscle rescue

homeopathic gel

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

MUSCLE RESCUE

arnica montana, rhus toxicodendron, phytolacca decandra, pulsatilla, ruta graveolens gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 46 -0 0 35

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

3 [hp_X]

in 1 g

TO XICO DENDRO N PUBESCENS LEAF (UNII: 6 IO18 2RP7A) (TOXICODENDRON

PUBESCENS LEAF - UNII:6 IO18 2RP7A)

TOXICODENDRON

PUBESCENS LEAF

3 [hp_X]

in 1 g

PHYTO LACCA AMERICANA RO O T (UNII: 11E6 VI8 VEG) (PHYTOLACCA AMERICANA

ROOT - UNII:11E6 VI8 VEG)

PHYTOLACCA AMERICANA

ROOT

12 [hp_X]

in 1 g

PULSATILLA VULGARIS (UNII: I76 KB35JEV) (PULSATILLA VULGARIS -

UNII:I76 KB35JEV)

PULSATILLA VULGARIS

12 [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

12 [hp_X]

in 1 g

Peaceful Mountain, Inc.

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)

PEG-8 DIMETHICO NE (UNII: GIA7T76 4OD)

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)

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

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

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

SALIX ALBA BARK (UNII: 20 5MXS71H7)

WITCH HAZEL (UNII: 10 1I4J0 U34)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:438 46 -0 0 35-1

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 8 /0 7/20 13

Labeler -

Peaceful Mountain, Inc. (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 35) , api manufacture(438 46 -0 0 35) , label(438 46 -0 0 35) ,

pa c k(438 46 -0 0 35)

Revised: 8/2013

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