MUSCLE ICE- phytolacca decandra, symphytum officinale, bellis perennis, ledum palustre, ruta graveolens, magnesia phosphorica, silicea gel

Muscle Ice by

Drug Labeling and Warnings

Muscle Ice by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

 Phytolacca decandra 1X, Symphytum officinale 3X, Bellis perennis 6X, Ledum palustre 6X, Ruta graveolens 6X, Magnesia phosphorica 9X, Silicea 9X

INDICATIONS:

 For the temporary relief of minor aches and pains of muscles and joints.**

**These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

WARNINGS:

FOR EXTERNAL USE ONLY. 

Avoid contact with eyes.  If condition worsens, or if symptoms persist for more than 7 days, discontinue use of this product and consult a doctor.  Do not apply to wounds or damaged skin.  Do not bandage tightly.

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.

DIRECTIONS:

Adults and children 2 years of age and older:  Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Consult a doctor.

INACTIVE INGREDIENTS:

Aloe vera concentrate, Camphor essential oil, Carbomer, Edetate disodium, Ginger essential oil, Lavender essential oil, PEG-33, PEG-8 dimethicone, PEG-14, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Purified water, Sodium hydroxide, St. John's Wort essential oil, Vitamin E (soy).

KEEP OUT OF REACH OF CHILDREN:

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact Poison Control Center right away.

INDICATIONS:

 For the temporary relief of minor aches and pains of muscles and joints.**

**These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain
THE HEIGHT OF HEALTH

muscle ice

homeopathic pain relieving gel

paraben-free
organic and wild-crafted herbs

formulated in boulder, co

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

INGREDIENTS AND APPEARANCE

MUSCLE ICE 
phytolacca decandra, symphytum officinale, bellis perennis, ledum palustre, ruta graveolens, magnesia phosphorica, silicea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	1 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	6 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_X]  in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	9 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	9 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR OIL (UNII: 75IZZ8Y727)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
EDETIC ACID (UNII: 9G34HU7RV0)
GINGER OIL (UNII: SAS9Z1SVUK)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPERICUM OIL (UNII: OZU2FC70HY)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0002-1	1814 g in 1 JUG; Type 0: Not a Combination Product	05/25/2012	11/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/25/2012	11/11/2020

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0002) , api manufacture(43846-0002) , label(43846-0002) , pack(43846-0002)