FDA.reportPublic FDA data

Muscle Ice

Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2016-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:20:54

Label at a glance#

ProductMuscle Ice
Active ingredientPHYTOLACCA AMERICANA ROOT, COMFREY ROOT, BELLIS PERENNIS, LEDUM PALUSTRE TWIG, RUTA GRAVEOLENS FLOWERING TOP, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SILICON DIOXIDE
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS:

OTC - PURPOSE SECTION

 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:

WARNINGS SECTION

FOR EXTERNAL USE ONLY. 

Avoid contact with eyes.  If condition worsens, or if symptoms persist for more than 7 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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe vera concentrate, Camphor essential oil, Carbomer, Edetate disodium, Ginger essential oil, Lavender essential oil, PEG-33, PEG-8 dimethicone, PEG-14, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Purified water, Sodium hydroxide, St. John's Wort essential oil, Vitamin E (soy).

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact Poison Control Center right away.

INDICATIONS:

INDICATIONS & USAGE SECTION

 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.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

peaceful mountain
THE HEIGHT OF HEALTH

muscle ice

homeopathic pain relieving gel

paraben-free
organic and wild-crafted herbs

formulated in boulder, co

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

Muscle IceMuscle Ice

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UY1
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQ1
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0P1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3Q1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587S1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
BELLIS PERENNISACTIVE MOIETY2HU33I03UY1
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQ1
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0P1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587S1
SILICONACTIVE MOIETYZ4152N8IUI1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CAMPHOR OILINACTIVE INGREDIENT75IZZ8Y7271
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)INACTIVE INGREDIENT59TL3WG5CO1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV01
GINGER OILINACTIVE INGREDIENTSAS9Z1SVUK1
HYPERICUM OILINACTIVE INGREDIENTOZU2FC70HY1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764OD1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33A1
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5R1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43846-000243846-0002-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
COMFREY ROOTM9VVZ08EKQACTIB
BELLIS PERENNIS2HU33I03UYACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
MENTHOLL7T10EIP3AIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR OIL75IZZ8Y727IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
EDETIC ACID9G34HU7RV0IACT
GINGER OILSAS9Z1SVUKIACT
LAVENDER OILZBP1YXW0H8IACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYPERICUM OILOZU2FC70HYIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 273 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
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MENTHOLMENTHOLL7T10EIP3APOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
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POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCUTANEOUS31.45 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM, AUGMENTED / TOPICAL6 mgExact identifier — unii candidate
174 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii candidate
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SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / SUBLINGUAL0.16 mgExact identifier — unii candidate
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.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
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POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SUSPENSION / TOPICAL0.06 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM / BUCCAL0.09 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADISCALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
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MENTHOLMENTHOLL7T10EIP3ATABLET / SUBLINGUAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33APASTE / DENTAL4.96 %w/wExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRADERMALADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPRAY, METERED / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
174 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
25c5d5b2-c318-45c4-b18b-5267f586c86267cd0c25-bd2c-4c76-b82f-7248acc783082016-12-29WarningsExact identifier
spl id: 25c5d5b2-c318-45c4-b18b-5267f586c862
spl set id: 67cd0c25-bd2c-4c76-b82f-7248acc78308

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.