MUSCLE ICE- phytolacca deccandra, 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 Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

WARNINGS

WARNINGS:  For external use only.  Avoid contact with eyes.  If condition worsens, or if symptoms persist for more that 7 days or clear up and occur again within a few 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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

INACTIVE INGREDIENTS:  Aloe vera, Camphor Essential oil, Carbomer, Edetate disodium, Ginger essential oil, Lavender essential oil, PEG-33, PEG-8 dimethicone, PEG-14, Phenoxyenthanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Purified water, Sodium hydroxide, St. John's wort essential oil, Vitamin E (soy), Menthol.

non-greasy - no petroleum - no animal testing

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

QUESTIONS

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

patent pending

PRINCIPAL DISPLAY PANEL

muscle ice

organic and wild-crafted herbs

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic

pain relieving gel

paraben-free

formulated in boulder, co

Net wt. 3.5 oz. (100 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0336
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 - UNII:Z4152N8IUI)	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)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GINGER OIL (UNII: SAS9Z1SVUK)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPERICUM OIL (UNII: OZU2FC70HY)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) (UNII: 59TL3WG5CO)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57520-0336-1	100 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/31/2011

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture