MUSCLE ICE (phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, whey protein, magnesia phosphorica, silicea, menthol- crystals 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, Bellis Perennis 6X, Ledum Palustre 6X, Ruta Graveolens 6X, Symphytum Officinale 6X, Whey Protein 6X, Magnesia Phosphorica 9X, Silicea 9X, Menthol 4%

INDICATIONS:

May temporarily relieve minor aches and pains of muscles and joints.**

**These statements are based upon traditional homeopathic principles. 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 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.

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.

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.

INDICATIONS:

May temporarily relieve minor aches and pains of muscles and joints.**

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

INACTIVE INGREDIENTS:

Purified Water, Whey Protein Concentrate (Milk), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Sodium Hydroxide (Solution), Tocopherols (derived from Soy Bean), Edetate Disodium (EDTA), Potassium Sorbate, Camphor Essential Oil (Wood), Ginger Essential Oil (Root), Lavender Essential Oil (Flower), St. John’s Wort Essential Oil (Aerial Parts)

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579 888-303-3388

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

muscle ice

formulated in boulder, co

Net wt. 2 oz. (57 g)

INGREDIENTS AND APPEARANCE

MUSCLE ICE 
phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, whey protein, magnesia phosphorica, silicea, menthol (crystals) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0064
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
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
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 1 g
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6)	WHEY	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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)
GINGER (UNII: C5529G5JPQ)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0064-1	57 g in 1 PACKAGE; Type 0: Not a Combination Product	10/17/2016	03/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/17/2016	03/23/2022

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0064) , api manufacture(43846-0064) , label(43846-0064) , pack(43846-0064)