MUSCLE ICE (phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, 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:

(in gel): 4% of Menthol; 0.20% of Bellis 6X, Ledum Palustre 6X, Phytolacca Decandra 4X, Ruta Graveolens 6X, Symphytum Officinale 6X; 0.001% of Magnesia Phosphorica 9X, Silicea 9X.

INDICATIONS:

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

**Claims based on traditional homeopathic principles, not accepted medical evidence. Not FDA evaluated.

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, or mucous membranes. 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 saftey 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:Apply to affected area not more than 3 to 4 times daily.

Children2 years of age and older: Consult a health professional. Do not use on children under 2 years of age.

INDICATIONS:

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

**Claims based on traditional homeopathic principles, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Purified Water, Aloe Vera Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide (Solution), Tocopherols (Derived from Soy Bean), EDETATE Disodium (EDTA), Ginger (Zingiber Officinale) Root Oil, English Lavender (Lavandula Angustifolia) Flower Oil, Spanish Thyme (Thymus Zygis) Aerial Parts Oil, St. John’s Wort (Hypericum Perforatum) Aerial Parts Oil, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid.

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

Net wt. 2 oz (57 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0073
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	4 [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
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)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SPANISH THYME OIL (UNII: U14667H96E)
GINGER OIL (UNII: SAS9Z1SVUK)
LAVENDER OIL (UNII: ZBP1YXW0H8)
HYPERICUM OIL (UNII: OZU2FC70HY)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0073-1	57 g in 1 TUBE; Type 0: Not a Combination Product	03/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/20/2020

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0073) , api manufacture(43846-0073) , label(43846-0073) , pack(43846-0073)