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

MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)) GEL [PEACEFUL MOUNTAIN, INC.]
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NDC 43846-0067-1
Set ID f85cbe3a-abe6-470f-8959-f6d7e0e52f66
Category HUMAN OTC DRUG LABEL
Packager Peaceful Mountain, Inc.
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, Menthol (Crystals) 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.

    Do not use if safety seal is broken or missing.

  • 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

    patent pending

  • PACKAGE LABEL DISPLAY:

    peaceful mountain

    THE HEIGHT OF HEALTH

    muscle ice

    homeopathic pain

    relieving gel

    paraben-free

    formulated in boulder, co

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

    Muscle Ice 1/2 Gal

  • INGREDIENTS AND APPEARANCE
    MUSCLE ICE 
    phytolacca decandra, symphytum officinale, bellis perennis, ledum palustre, ruta graveolens, magnesia phosphorica, silicea, menthol (crystals) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0067
    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
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL844 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    WHEY (UNII: 8617Z5FMF6)  
    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)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0067-11814 g in 1 JUG; Type 0: Not a Combination Product09/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/14/2016
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0067) , api manufacture(43846-0067) , label(43846-0067) , pack(43846-0067)

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