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

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.**

**These statements are based upon traditional homeopathic practice. 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 with 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:

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

**These statements are based up on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Aloe Vera, Camphor Essential Oil, Carbomer (Ultrez 21), Edetate Disodium (EDTA), Ginger Essential Oil, Lavender Essential Oil, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), St. John's Wort Essential Oil, Vitamin E Oil, Menthol.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE DISPLAY LABEL:

muscle ice

peaceful mountain

homeopathic

pain relieving gel

Net wt. 3.7 oz. (105 g)

image description

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:43846-0022
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
ALOE (UNII: V5VD430YW9)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GINGER OIL (UNII: SAS9Z1SVUK)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYPERICUM OIL (UNII: OZU2FC70HY)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0022-1105 g in 1 TUBE; Type 0: Not a Combination Product09/25/201309/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/25/201309/01/2022
Labeler - Peaceful Mountain (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0022) , api manufacture(43846-0022) , label(43846-0022) , pack(43846-0022)

Revised: 12/2021
 
Peaceful Mountain