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

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

MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA,) GEL [APOTHECA COMPANY]
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NDC 57520-0484-1
Set ID 202fabc1-2714-4a06-a0ae-40125c3cf548
Category HUMAN OTC DRUG LABEL
Packager Apotheca Company
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

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


  • PURPOSE

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

  • WARNINGS

    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.


  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    INACTIVE INGREDIENTS:  Aloe vera concentrate, Camphor essential oil, Carbomer, Purified water, Edetate disodium, Ginger essential oil, Lavender essential oil, Peg-33, Peg-8, Demithicone, Peg-14, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Sodium hydroxide, St. John's wort essential oil, Vitamin E oil (derived from Soy Bean), Menthol.


  • 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.


  • INDICATIONS & USAGE

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


  • QUESTIONS


    Dist by Peaceful Mountain, Inc.

    Woodbine, IA 51579

    888-303-3388

    www.peacefulmountain.com

  • PRINCIPAL DISPLAY PANEL


    peaceful mountain

    THE HEIGHT OF HEALTH

    muscle ice

    homeopathic pain relieving gel

    formulated in boulder, co

    Net wt. 0.24 oz. (7 g)

    Muscle Ice

  • 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:57520-0484
    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 LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X) COMFREY LEAF3 [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 - UNII:Z4152N8IUI) SILICON DIOXIDE9 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    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 1500 (UNII: 1212Z7S33A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0484-17 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/19/2011
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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