Muscle Ice: Homeopathic Product Information

MUSCLE ICE- phytolacca americana root, bellis perennis, ledum palustre twig, ruta graveolens flowering top, comfrey root, magnesium phosphate, dibasic trihydrate and silicon dioxide gel
Peaceful Mountain, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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.

Children 2 years of age and older: C onsult 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)

Muscle Ice
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT 4 [hp_X] in 1 g
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS 6 [hp_X] in 1 g
LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 g
RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X] in 1 g
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 6 [hp_X] in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 9 [hp_X] in 1 g
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 9 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
MENTHOL
WATER
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
SODIUM HYDROXIDE
POLYETHYLENE GLYCOL 1600
PEG-8 DIMETHICONE
POLYETHYLENE GLYCOL 700
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
TOCOPHEROL
ALOE VERA LEAF
EDETATE DISODIUM
POTASSIUM SORBATE
SPANISH THYME OIL
GINGER OIL
LAVENDER OIL
HYPERICUM OIL
ALCOHOL
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43846-0073-1 57 g in 1 TUBE None
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 Operations
Apotheca Company 844330915 manufacture (43846-0073), api manufacture (43846-0073), label (43846-0073), pack (43846-0073)

Revised: 08/2022 Peaceful Mountain, Inc.

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