MUSCLE ICE - phytolacca decandra, symphytum officinale, bellis perennis, ledum palustre, ruta graveolens, magnesia phosphorica, silicea, gel 
Apotheca Company

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.

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Drug Facts:

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


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

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.

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 INGREDIENTS:  Menthol, Aloe vera concentrate, Camphor essential oil, Carbomer, Demineralized water, Edetate disodium, Ginger essential oil, Lavender essential oil, PEG-33, PEG-8, Dimethicone, PEG-14, Phenoxyethanol, Caprylyl glycol, Sorbid acid, Potassium sorbate, Sodium hydroxide, St. John's Wort essential oil, Vitamin E oil.


non-greasy - no petroleum - no animal testing

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


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

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

patent pending

peaceful mountain

THE HEIGHT OF HEALTH

muscle ice

homeopathic pain relieving gel

paraben-free

organic and wild-crafted herbs

formulated in boulder, co

Net wt. 4 lbs. (64 oz.) (1.8 kg)

Muscle Ice

MUSCLE ICE 
phytolacca decandra, symphytum officinale, bellis perennis, ledum palustre, ruta graveolens, magnesia phosphorica, silicea, gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0395
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT1 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS6 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG6 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]  in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE9 [hp_X]  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE9 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GINGER OIL (UNII: SAS9Z1SVUK)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
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)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0395-11814 g in 1 JUG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/11/201105/09/2016
Labeler - Apotheca Company (844330915)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(57520-0395) , api manufacture(57520-0395) , label(57520-0395) , pack(57520-0395)

Revised: 8/2015
Document Id: bd0a3317-5941-40bc-9672-da6983fc5163
Set id: ed1133ae-8ad2-4925-adf0-0c8630b8c166
Version: 3
Effective Time: 20150827
 
Apotheca Company