MUSCLE ICE (PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, WHEY PROTEIN, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)) GEL [PEACEFUL MOUNTAI

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  • MUSCLE ICE (PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, WHEY PROTEIN, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)) GEL [PEACEFUL MOUNTAI

MUSCLE ICE (PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, WHEY PROTEIN, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)) GEL [PEACEFUL MOUNTAI
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NDC 43846-0070-1
Set ID 2a82d211-6b5f-4525-a9f7-bb8ca84718b4
Category HUMAN OTC DRUG LABEL
Packager Peaceful Mountain, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENTS:

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

  • INDICATIONS:

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

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • 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.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Purified Water, Caprylic/Capric Triglycerides, Whey Protein Concentrate (Milk), Aloe Barbadensis Leaf Juice, Benzyl Alcohol (and) Ethylhexylglycerin (and) Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer and Sodium Hydroxide

  • QUESTIONS:

    Dist. by Peaceful Mountain, Inc.

    Woodbine, IA 51579

    888-303-3388

    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    muscle

    ice

    peaceful mountain

    THE HEIGHT OF HEALTH

    homeopathic

    pain relieveing gel

    paraben free

    formulated in

    boulder, co

    Net wt. 2 oz. (57 g)

    Muscle Ice

  • INGREDIENTS AND APPEARANCE
    MUSCLE ICE 
    phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, whey protein, magnesia phosphorica, silicea, menthol (crystals) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT4 [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
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0070-157 g in 1 TUBE; Type 0: Not a Combination Product05/03/201805/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/03/201805/03/2023
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0070) , api manufacture(43846-0070) , label(43846-0070) , pack(43846-0070)
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