MUSCLE ICE (phytolacca decandra, symphytum officinale, bellis perennis, ledum palustre, ruta graveolens, 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, Symphytum Officinale 3X, Bellis Perennis 6X, Ledum Palustre 6X, Ruta Graveolens 6X, Magnesia Phosphorica 9X, Silicea 9X, Menthol (Crystals) 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.

Do not use if safety seal is broken or missing.

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, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Sodium Hydroxide Solution, Acrylates,C10-30 Alkyl-Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Tocopherol (Soy), Edetate Disodium, Potassium Sorbate, Camphor Oil (Wood), Ginger Oil (Root), Lavender Oil (Flower), St. John’s Wort Oil (Aerial Parts)

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

muscle ice

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic

pain relieving gel

paraben-free

formulated in

boulder, co

Net wt. 2 oz. (57 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0051
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	700 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
WHEY (UNII: 8617Z5FMF6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CAMPHOR OIL (UNII: 75IZZ8Y727)
GINGER OIL (UNII: SAS9Z1SVUK)
LAVENDER OIL (UNII: ZBP1YXW0H8)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0051-1	57 g in 1 TUBE; Type 0: Not a Combination Product	04/26/2016	09/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/26/2016	09/16/2021

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0051) , api manufacture(43846-0051) , label(43846-0051) , pack(43846-0051)