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

MUSCLE ICE (PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, WHEY PROTEIN, MAGNESIA PHOSPHORICA, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]
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NDC 43846-0063-1
Set ID d2408420-c42b-4141-8a97-7b05b561c7a1
Category HUMAN OTC DRUG LABEL
Packager Peaceful Mountain, Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENTS:

    Phytolacca Decandra 1X, Bellis Perennis 6X, Ledum Palustre 6X, Ruta Graveolens 6X, Symphytum Officinale 6X, Whey Protein 6X, Magnesia Phosphorica 9X, Silicea 9X, Menthol 4%

  • INDICATIONS:

    May temporarily relieve minor aches and pains of muscles and joints.**

    **These statements are based upon traditional homeopathic principles. 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 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.

  • 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:

    May temporarily relieve minor aches and pains of muscles and joints.**

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Purified Water, Whey Protein (Milk), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf, Sodium Hydroxide (Solution), Tocopherols (Derived From Soy Bean), Edetate Disodium (EDTA), Potassium Sorbate, Camphor Essential Oil (Wood), Ginger Essential Oil (Root), Lavender Essential Oil (Flower), Hypericum Perforatum

  • QUESTIONS:

    Dist. by Peaceful Mountain, Inc.
    Woodbine, IA 51579  •  888-303-3388
    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    peaceful mountain

    THE HEIGHT OF HEALTH

    homeopathic gel

    muscle ice

    formulated in boulder, co

    Net wt. 0.25 oz. (7 g)

    Muscle Ice

  • INGREDIENTS AND APPEARANCE
    MUSCLE ICE 
    phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, whey protein, magnesia phosphorica, silicea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0063
    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
    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
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 g
    WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6) WHEY6 [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)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)  
    GINGER (UNII: C5529G5JPQ)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0063-17 g in 1 PACKET; Type 0: Not a Combination Product08/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/04/2016
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0063) , api manufacture(43846-0063) , label(43846-0063) , pack(43846-0063)

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