MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA) GEL [PEACEFUL MOUNTAIN]

MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA) GEL [PEACEFUL MOUNTAIN]
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NDC 43846-0022-1
Set ID 075810e7-9e1b-4168-b5c6-fc335491bdd4
Category HUMAN OTC DRUG LABEL
Packager Peaceful Mountain
Generic Name
Product Class
Product Number
Application Number
  • 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

  • INGREDIENTS AND APPEARANCE
    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) (COLLOIDAL 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2013
    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)

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