Label: MUSCLE ICE (phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, magnesia phosphorica, silicea, menthol- crystals gel
- NDC Code(s): 43846-0073-1
- Packager: Peaceful Mountain, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 13, 2024
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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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, or mucous membranes. 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 saftey seal is broken or missing.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
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INACTIVE INGREDIENTS:
Purified Water, Aloe Vera Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide (Solution), Tocopherols (Derived from Soy Bean), EDETATE Disodium (EDTA), Ginger (Zingiber Officinale) Root Oil, English Lavender (Lavandula Angustifolia) Flower Oil, Spanish Thyme (Thymus Zygis) Aerial Parts Oil, St. John’s Wort (Hypericum Perforatum) Aerial Parts Oil, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid.
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- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
MUSCLE ICE
phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, magnesia phosphorica, silicea, menthol (crystals) gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0073 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 4 [hp_X] in 1 g BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE 6 [hp_X] in 1 g LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X] in 1 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 1 g MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 9 [hp_X] in 1 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 9 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) PEG-8 DIMETHICONE (UNII: GIA7T764OD) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TOCOPHEROL (UNII: R0ZB2556P8) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SPANISH THYME OIL (UNII: U14667H96E) GINGER OIL (UNII: SAS9Z1SVUK) LAVENDER OIL (UNII: ZBP1YXW0H8) HYPERICUM OIL (UNII: OZU2FC70HY) ALCOHOL (UNII: 3K9958V90M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0073-1 57 g in 1 TUBE; Type 0: Not a Combination Product 03/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/20/2020 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0073) , api manufacture(43846-0073) , label(43846-0073) , pack(43846-0073)
